Data / Medical devices / United States / Bausch & Lomb Incorporated
Bausch & Lomb Incorporated: FDA-registered device maker in Rochester, NY, United States, 144 510(k) clearances and 29 PMA approvals
Bausch & Lomb Incorporated is registered with the FDA (registration 1313525) in Rochester, NY, United States. It lists 205 device types. The FDA files 144 510(k) clearances and 29 PMA approvals under its listings, the newest dated March 25, 2026. 25 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1313525
- FEI number
- 1317628
- Address
- 1400 North Goodman Street, Rochester, NY, United States, 14609
- Owner or operator
- Bausch & Lomb Incorporated (9913003)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- February 22, 1989
- Registered through
- 2026
- Brand names listed
- CX9626 25GA SYST -6/box
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 144.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 25, 2026 | K252052 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | HQC | Substantially Equivalent | Bausch and Lomb, Incorporated | accessdata.fda.gov |
| October 10, 2024 | K242389 | EyeGility Inserter for Preloaded enVista IOLs | MSS | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| July 26, 2024 | K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | HQC | Substantially Equivalent | Bausch and Lomb, Incorporated | accessdata.fda.gov |
| November 17, 2023 | K230954 | Samfilcon B Custom Contact Lens | LPL | Substantially Equivalent | Bausch + Lomb, Incorporated | accessdata.fda.gov |
| December 6, 2022 | K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting Drops | LPN | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| December 3, 2021 | K211786 | Independent Corneal Viewing Chamber (IVC-21) | LYX | Substantially Equivalent | Bausch + Lomb, Incorporated | accessdata.fda.gov |
| May 28, 2021 | K202932 | ABT12 multi-purpose solution | LPN | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| May 24, 2021 | K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| September 23, 2020 | K200416 | Boston One Step Liquid Enzymatic Cleaner | MRC | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| June 4, 2020 | K200057 | bioli lOL Delivery System | MSS | Substantially Equivalent | Ast Products, Inc. | accessdata.fda.gov |
| June 2, 2020 | K200528 | Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism | LPL | Substantially Equivalent | Bausch + Lomb, Incorporated | accessdata.fda.gov |
| October 4, 2019 | K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded | MSS | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| February 12, 2019 | K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens | HQD | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| November 30, 2018 | K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| August 10, 2018 | K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner | MRC | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| March 27, 2018 | K180319 | Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution | MRC | Substantially Equivalent | Bausch and Lomb, Incorporated | accessdata.fda.gov |
| November 27, 2017 | K173089 | Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions | MRC | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| July 18, 2017 | K163714 | OSSIX BONE | NPM | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
| July 17, 2017 | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | HQD | Substantially Equivalent | Bausch + Lomb, Incorporated | accessdata.fda.gov |
| April 19, 2017 | K170052 | Stellaris Elite vision enhancement system | HQC | Substantially Equivalent | Bausch+Lomb | accessdata.fda.gov |
| April 11, 2017 | K170483 | Bausch + Lomb Sensitive Eyes Plus Saline Solution | LPN | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| March 24, 2017 | K162342 | Stellaris Elite Vision Enhancement System | HQC | Substantially Equivalent | Bausch+Lomb | accessdata.fda.gov |
| November 25, 2016 | K161819 | NNR06 Multi-Purpose Solution | LPN | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| August 11, 2016 | K161622 | LensGiene Sterile Saline Solution | LPN | Substantially Equivalent | Optics Laboratory, Inc. | accessdata.fda.gov |
| August 4, 2016 | K160281 | OSSIX PLUS | NPL | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
| August 4, 2016 | K153549 | OSSIX VOLUMAX | NPL | Substantially Equivalent | Datum Dental, Ltd. | accessdata.fda.gov |
| July 6, 2016 | K161012 | Easy-Load Lens Delivery System | MSS | Substantially Equivalent | Bausch and Lomb, Inc., | accessdata.fda.gov |
| April 29, 2016 | K153168 | Bi-Blade Vitrectomy Cutter | HQE | Substantially Equivalent | Medical Instrument Development Laboratories | accessdata.fda.gov |
| January 28, 2016 | K153186 | Adjustable Fixation Device | MBI | Substantially Equivalent | Arthrocare Corp. | accessdata.fda.gov |
| September 11, 2015 | K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | MPA | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| May 22, 2015 | K151102 | Bausch + Lomb Injector System | MSS | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| February 13, 2015 | K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| July 15, 2014 | K141063 | LINSCAN 808, LINSCAN 980 | GEX | Substantially Equivalent | Gme (German Medical Engineering) GmbH | accessdata.fda.gov |
| March 12, 2014 | K133486 | STELLARIS PC VISION ENHANCEMENT SYSTEM | HQC | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| February 14, 2014 | K133242 | STELLARIS VISION ENHANCEMENT SYSTEM | HQC | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| January 9, 2014 | K131958 | BAUSCH & LOMB INJECTOR SYSTEM | MSS | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| January 3, 2014 | K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM | MSS | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| December 27, 2013 | K132481 | EASY-LOAD LENS DELIVERY SYSTEM | MSS | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| December 20, 2013 | K132715 | BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| September 17, 2013 | K132593 | CRYSTALSERT DELIVERY SYSTEM | MSS | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| September 11, 2013 | K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, | LPL | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| June 26, 2013 | K122997 | 23GA CURVED ILLUMINATING LASER PROBE | HQB | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| June 14, 2013 | K130193 | FRAXEL DUAL 1550/1927 LASER SYSTEM | GEX | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| April 30, 2013 | K122905 | PEREGRINE 23GA CURVED LASER PROBE | HQB | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| September 28, 2012 | K113852 | BAUSCH & LOMB IOL INJECTOR | MSS | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| September 17, 2012 | K120328 | ORIGINS LIPOHARVESTING SYSTEM | MUU | Substantially Equivalent | Sound Surgical Technologies, LLC | accessdata.fda.gov |
| June 5, 2012 | K121515 | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM | ONF | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| June 5, 2012 | K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| April 2, 2012 | K120433 | CLEAR + BRILLIANT LASER SYSTEM | ONG | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| October 25, 2011 | K112192 | NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS | MVN | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| October 20, 2011 | K112626 | LIPSONIX(R) SYSTEM MODEL 2 | OHV | Substantially Equivalent | Medicis Technologies Corporation | accessdata.fda.gov |
| June 23, 2011 | K110306 | SOUND SURGICAL VASER 2.1 LIPO SYSTEM | QPB | Substantially Equivalent | Sound Surgical Technologies, LLC | accessdata.fda.gov |
| May 3, 2011 | K110349 | CLEAR+BRILLIANT LASER SYSTEM | ONG | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| April 4, 2011 | K110255 | SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM | QPB | Substantially Equivalent | Sound Surgical Technologies, LLC | accessdata.fda.gov |
| September 8, 2010 | K101490 | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US | ONG | Substantially Equivalent | Thermage, Inc. | accessdata.fda.gov |
| August 17, 2010 | K101325 | STELLARIS PC VISION ENHANCEMENT SYSTEM | HQC | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| May 6, 2010 | K091615 | MED CONTOUR | IMI | Substantially Equivalent | General Project S.R.L. | accessdata.fda.gov |
| December 11, 2009 | K093642 | NEUTRASAL | LFD | Substantially Equivalent | Invado Pharmaceuticals | accessdata.fda.gov |
| November 18, 2009 | K083757 | BPZ02 MULTIPURPOSE SOLUTION | LYL | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| October 14, 2009 | K091420 | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 | ONG | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| July 28, 2009 | K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 | MSS | Substantially Equivalent | Medicel AG | accessdata.fda.gov |
| June 26, 2009 | K090580 | THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES | GEI | Substantially Equivalent | Solta Medical, Inc. | accessdata.fda.gov |
| March 23, 2009 | K081346 | HOYA IS INJECTOR SYSTEM | MSS | Substantially Equivalent | Hoya Surgical Optics, Inc. | accessdata.fda.gov |
| January 9, 2009 | K083730 | ISOLAZ | GEX | Substantially Equivalent | Aesthera Corporation | accessdata.fda.gov |
| October 16, 2008 | K082944 | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM | MSS | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| August 28, 2008 | K082132 | BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK | HQC | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| July 1, 2008 | K080915 | FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES | GEX | Substantially Equivalent | Reliant Technologies, Inc. | accessdata.fda.gov |
| June 10, 2008 | K080755 | SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | MVN | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| March 12, 2008 | K073023 | STERILS SINGLE-USE I/A HANDPIECES | HQC | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| November 1, 2007 | K070669 | IOL INJECTOR SET | KYB | Substantially Equivalent | Medicel AG | accessdata.fda.gov |
| August 15, 2007 | K071266 | BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| August 2, 2007 | K071043 | BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES | HQD | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| May 17, 2007 | K070284 | FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM) | GEX | Substantially Equivalent | Reliant Technologies, Inc. | accessdata.fda.gov |
| April 27, 2007 | K063808 | FRAXEL IV SR LASER SYSTEM | GEX | Substantially Equivalent | Reliant Technologies, Inc. | accessdata.fda.gov |
| March 7, 2007 | K063694 | AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 | KYB | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| January 31, 2007 | K062303 | FRAXEL II SR LASER SYSTEM | GEX | Substantially Equivalent | Reliant Technologies, Inc. | accessdata.fda.gov |
| December 19, 2006 | K063331 | BAUSCH & LOMB NGX MICROSURGICAL SYSTEM | HQC | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| September 7, 2006 | K062048 | AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM | GEX | Substantially Equivalent | Aesthera Corporation | accessdata.fda.gov |
| June 22, 2006 | K061157 | SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS | MVN | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| June 21, 2006 | K061024 | PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 | HQF | Substantially Equivalent | Peregrine Surgical , Ltd. | accessdata.fda.gov |
| February 22, 2006 | K053260 | OSSIX -PLUS | NPL | Substantially Equivalent | Colbar Lifescience , Ltd. | accessdata.fda.gov |
| January 30, 2006 | K053124 | BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES | HQD | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| October 19, 2004 | K040839 | COMPLETE BLINK-N-CLEAN LENS DROPS | MRC | Substantially Equivalent | Advanced Medical Optics, Inc. | accessdata.fda.gov |
| August 16, 2004 | K041998 | PHACO CHOP NEEDLES | HQC | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| February 10, 2004 | K033941 | MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK | HQF | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| February 4, 2004 | K033942 | THERMAGE THERMACOOL SYSTEM | GEI | Substantially Equivalent | Thermage, Inc. | accessdata.fda.gov |
| September 25, 2003 | K032030 | BLINK CL LUBRICANT EYE DROPS | LPN | Substantially Equivalent | Advanced Medical Optics, Inc. | accessdata.fda.gov |
| May 2, 2003 | K024289 | BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION | MRC | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| September 11, 2002 | K022051 | SOUNDVASER SYSTEM | QPB | Substantially Equivalent | Sound Surgical Technologies, LLC | accessdata.fda.gov |
| August 22, 2002 | K022128 | BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| May 16, 2002 | K020927 | BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS | LPL | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| April 3, 2002 | K013762 | RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| November 20, 2001 | K013232 | CYBERCASES BY BAUSCH & LOMB | LRX | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| October 2, 2001 | K012435 | ENTRY SITE ALIGNMENT SYSTEM MODEL # CX9626 | NGY | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| September 12, 2001 | K011945 | RIGID GAS PERMEABLE CONTACT LENS SOLUTION | HQD | Substantially Equivalent | Polymer Technology Corp. | accessdata.fda.gov |
| July 2, 2001 | K011199 | PROVIEW EYE PRESSURE MONITOR | HKY | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| February 16, 2001 | K003932 | BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY | HQD | Substantially Equivalent | Polymer Technology | accessdata.fda.gov |
| October 31, 2000 | K002025 | RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Polymer Technology | accessdata.fda.gov |
| August 28, 2000 | K001960 | RIGID GAS PERMEABLE CONTACT LENS | HQD | Substantially Equivalent | Polymer Technology | accessdata.fda.gov |
| July 19, 2000 | K000944 | THERMAGE THERMACOOL SYSTEM | GEI | Substantially Equivalent | Thermage, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 10, 2024 | P240005 | enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) | MFK | 10 | October 23, 2026 | accessdata.fda.gov |
| February 22, 2023 | P220009 | StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD) | LZP | 0 | February 22, 2023 | accessdata.fda.gov |
| July 22, 2022 | P210005 | IC-8 Apthera Intraocular Lens (IOL) | POE | 10 | July 14, 2026 | accessdata.fda.gov |
| March 23, 2021 | P200025 | ClearVisc Ophthalmic Viscosurgical Device (OVD) | LZP | 0 | March 23, 2021 | accessdata.fda.gov |
| April 30, 2018 | P170035 | Bausch + Lomb Ultra (samfilcon A) Contact Lenses | LPM | 18 | September 14, 2026 | accessdata.fda.gov |
| September 26, 2008 | P080004 | HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS | HQL | 45 | October 25, 2023 | accessdata.fda.gov |
| September 5, 2008 | P060022 | AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT | HQL | 35 | September 3, 2026 | accessdata.fda.gov |
| June 7, 2004 | P010062 | EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR | NUU | 14 | December 16, 2025 | accessdata.fda.gov |
| November 14, 2003 | P030002 | CRYSTALENS MODEL AT-45 ACCOMMODATING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | NAA | 38 | April 8, 2022 | accessdata.fda.gov |
| October 23, 2003 | P010059 | MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C | MRJ | 10 | November 4, 2024 | accessdata.fda.gov |
| February 5, 1999 | P980006 | PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR | LPM | 35 | March 17, 2025 | accessdata.fda.gov |
| December 16, 1996 | P960022 | SOFLENS66(TM) | LPM | 13 | April 8, 2025 | accessdata.fda.gov |
| November 4, 1994 | P910071 | ADATOMED SILICONE OIL OP5000 | LWL | 17 | December 22, 2025 | accessdata.fda.gov |
| September 2, 1994 | P910061 | MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS | HQL | 24 | January 19, 2022 | accessdata.fda.gov |
| January 17, 1992 | P910056 | SOFLEX UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS | HQL | 58 | October 23, 2026 | accessdata.fda.gov |
| December 28, 1989 | P880090 | MODEL 120UV ANTERIOR CHAMBER INTRAOCULAR LENS | HQL | 28 | February 28, 2019 | accessdata.fda.gov |
| July 14, 1988 | P860023 | SENSITIVE EYES CLEANING/DISINFECTING SOLUTION | LPN | 9 | July 3, 1997 | accessdata.fda.gov |
| July 12, 1988 | P860047 | HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML | LZP | 32 | May 31, 2023 | accessdata.fda.gov |
| November 30, 1987 | P860022 | BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS | MWL | 57 | December 16, 2025 | accessdata.fda.gov |
| June 11, 1987 | P830013 | B&L SENSITIVE EYES(TM) DAILY CLEANER | LPN | 5 | April 13, 1994 | accessdata.fda.gov |
| March 28, 1986 | P840039 | ULTRA VIOLET (UV) AND NON-UV ABSORBING PMMA INTRAOCULAR LENSES | HQL | 45 | August 9, 2022 | accessdata.fda.gov |
| December 31, 1985 | P850068 | SILSOFT (ELASTOFILCON A) CONTACT LENSES | LPM | 14 | March 18, 2022 | accessdata.fda.gov |
| March 29, 1984 | P820070 | BOSTON LENS(R) CONDITIONING SOLUTION | LPN | 14 | July 13, 1990 | accessdata.fda.gov |
| March 19, 1984 | P820031 | SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION | LPN | 11 | March 10, 1997 | accessdata.fda.gov |
| March 16, 1984 | P820069 | BOSTON LENS(R) CLEANER | LPN | 12 | August 15, 1994 | accessdata.fda.gov |
| December 23, 1983 | P820065 | BOSTON LENS(R) LENS - CLEAR | HPX | 70 | February 16, 1994 | accessdata.fda.gov |
| October 18, 1983 | P810025 | AMVISC(R) | LZP | 37 | June 22, 2023 | accessdata.fda.gov |
| July 31, 1981 | P800024 | BAUSCH & LOMB STERILE PRESERVED SALINE SOLUTION | LPN | 16 | May 5, 1995 | accessdata.fda.gov |
| March 18, 1971 | N16895 | SOFLENS CONTACT LENSES (POLYMACON) | LPM | 96 | October 24, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 3, 2017 | 76874 | Class II | Terminated | LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are a | The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. out of an abundance of precaution, Bausch + Lomb is voluntarily recalling all product codes SKU manufacturing without the electro-polish control and penetration force testing. | accessdata.fda.gov |
| September 19, 2016 | 75324 | Class II | Terminated | PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. Per | Product was found to contain excess residual levels of hydrogen peroxide. | accessdata.fda.gov |
| July 11, 2016 | 74671 | Class II | Terminated | Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures. | Possible dull knife edge | accessdata.fda.gov |
| September 3, 2015 | 72161 | Class II | Terminated | BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Bio | The firm determined that 25 lots had been manufactured with a minor surface defect occurring in the optical surface on each lens. Complaints of Halo or Poor Visual Acuity. | accessdata.fda.gov |
| August 31, 2012 | 63057 | Class II | Terminated | Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy. | Posterior fluidics modules installed in the system may need to be recalibrated. | accessdata.fda.gov |
| July 27, 2011 | 59662 | Not yet classified | Terminated | Bausch & Lomb Stellaris Premium Vacuum Phaco Pack, Ref: BL5110, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the pha | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction | accessdata.fda.gov |
| June 30, 2011 | 59525 | Not yet classified | Terminated | Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disi | Muti-purpose solution bottles, lot GC1107 were packaged in a carton that was marked with an incorrect lot code and expiration date. | accessdata.fda.gov |
| December 22, 2010 | 57555 | Not yet classified | Terminated | Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb Place, Rochester, NY 14609 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfectio | There is a potential for some packages to not meet sterility requirements. | accessdata.fda.gov |
| April 20, 2010 | 55538 | Not yet classified | Terminated | Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Bausch & Lomb, Inc. Wilmington, MA 01887. Indicated for daily wear for the correction of re | The amount of D&C #6 Dye added to the formulation exceeded specified amounts. | accessdata.fda.gov |
| January 15, 2010 | 54268 | Not yet classified | Terminated | Bausch & Lomb Millennium Microsurgical System. | The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009. | accessdata.fda.gov |
| January 8, 2010 | 54200 | Not yet classified | Terminated | Bausch & Lomb Millennium Basic Venturi Phaco Pack, Models DP4305 and DP4305E, 12 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained in the | Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate | accessdata.fda.gov |
| November 19, 2009 | 53949 | Not yet classified | Terminated | Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only, STERILE. Manufactured by: Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759. Intraocular lens indicated for primary implant | Bausch & Lomb Incorporated, Rochester, NY is recalling their Silicone L161SE Intraocular Lens Lot 4916928 (23.5D) after receiving three customer complaints for what appears to be opacification of the intraocular lens. The opacification occurred within one week of implantation. In each reported case the surgeon explanted the lens. | accessdata.fda.gov |
| October 30, 2009 | 53873 | Not yet classified | Terminated | Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles. | The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors. | accessdata.fda.gov |
| August 17, 2009 | 52987 | Not yet classified | Terminated | Bausch & Lomb ReNu Multi-Purpose Solution, 12 fl.oz. (355 ml), Bausch & Lomb, Incorporated, Rochester, NY 14609. Product is used for For the cleaning, rinsing, disinfecting, and storage of soft contact lenses. | During routine testing the product failed to meet shelf life specifications. | accessdata.fda.gov |
| June 30, 2009 | 52602 | Not yet classified | Terminated | Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Bausch & Lomb Incorporated, Rochester, NY 14609. | The product failed to meet one of the shelf life specifications at the end of the expiry period. | accessdata.fda.gov |
| December 8, 2008 | 52652 | Not yet classified | Terminated | Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL. | Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits. | accessdata.fda.gov |
| April 23, 2008 | 47839 | Not yet classified | Terminated | Zyoptix XP Microkeratome maxon motor, Ref #ZXP09183. The label shows the product is manufactured by Bausch & Lomb Incorporated, Rochester, NY. | The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating. | accessdata.fda.gov |
| March 26, 2008 | 47422 | Not yet classified | Terminated | Bausch & Lomb Millennium Phacoemulsification Needles, Needle Tapered Hub 15 Degree, REF DP8115, 6 needles per pouch, nonsterile. | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable | accessdata.fda.gov |
| June 8, 2007 | 38230 | Not yet classified | Terminated | Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No., RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactured by: Bausch & Lomb Incorpora | Reports have been received of stromal incursions after use of the product. | accessdata.fda.gov |
| March 5, 2007 | 37507 | Not yet classified | Terminated | Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu Multi-Plus Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product | A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color. | accessdata.fda.gov |
| February 9, 2007 | 37281 | Not yet classified | Terminated | Bausch & Lomb Millennium Microsurgical System TSV 25 Ga. High Speed Vitrectomy Cutter, Catalog No. CX5825, packaged individually in a Tyvek pouch, 6/box, RX. The firm names on the label are Bausch & Lomb Incorporated, Ro | The cutter probe tip breaks during use. | accessdata.fda.gov |
| December 14, 2006 | 36980 | Not yet classified | Terminated | Bausch & Lomb Lightning High Speed Vitrectomy Cutter, Catalog #CX4804, 1/20-gauge high speed vitrectomy cutter per package. The firm name on the label is Bausch & Lomb incorporated, Rochester, NY. | The cutter tip could break during a procedure | accessdata.fda.gov |
| February 4, 2005 | 31043 | Not yet classified | Terminated | SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blister packs are labeled with -3.25 DS, -1.25DC, 170 degree Axis. Firm on label: Manufactured by Bausch | Portion of lot contains lenses with incorrect refractive power. | accessdata.fda.gov |
| November 10, 2003 | 27714 | Not yet classified | Terminated | CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes. | The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction. | accessdata.fda.gov |
| November 26, 2002 | 25105 | Not yet classified | Terminated | OPTIMA FW (polymacon) Visibility Tinted Contact Lenses, labeled as -2.25D, 8.7 mm. Responsible firm on the label: Bausch & Lomb Inc., Rochester, NY 14692. Each box contains six lenses. | Lenses labeled as -2.25 diopter contain -0.75 diopter lenses. | accessdata.fda.gov |
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Updated October 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.