Data / Medical devices / United States / Bausch & Lomb Incorporated
Bausch & Lomb Incorporated: FDA-registered device maker in Clearwater, FL, United States, 15 510(k) clearances and 11 PMA approvals
Bausch & Lomb Incorporated is registered with the FDA (registration 1119279) in Clearwater, FL, United States. It lists 10 device types. The FDA files 15 510(k) clearances and 11 PMA approvals under its listings, the newest dated October 10, 2024. 9 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1119279
- Address
- 21 Park Place BLVD. North, Clearwater, FL, United States, 33759
- Owner or operator
- Bausch & Lomb Incorporated (9913003)
- Roles
- Manufacturer
- First device listed
- April 22, 2005
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Surgical, Viscoelastic | LZP | 3 | Manufacturer | accessdata.fda.gov |
| Extended Depth Of Focus Intraocular Lens | POE | 3 | Manufacturer | accessdata.fda.gov |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Manufacturer | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Guide, Intraocular | KYB | 1 | Manufacturer | accessdata.fda.gov |
| Lens, Intraocular, Accommodative | NAA | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Intraocular, Toric Optics | MJP | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Multifocal Intraocular | MFK | 3 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Extended Wear | LPM | 3 | Manufacturer | accessdata.fda.gov |
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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 11, 2017 | K173480 | Crystalsert Lens Delivery System | MSS | Substantially Equivalent | Bausch & Lomb, Inc. | accessdata.fda.gov |
| July 6, 2016 | K161012 | Easy-Load Lens Delivery System | MSS | Substantially Equivalent | Bausch and Lomb, Inc., | accessdata.fda.gov |
| October 30, 2014 | K142851 | CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens | LPL | Substantially Equivalent | Unilens Corp., USA | accessdata.fda.gov |
| December 27, 2013 | K132481 | EASY-LOAD LENS DELIVERY SYSTEM | MSS | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| September 17, 2013 | K132593 | CRYSTALSERT DELIVERY SYSTEM | MSS | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| May 16, 2013 | K123736 | CRYSTALSERT DELIVERY SYSTEM | MSS | Substantially Equivalent | Bausch & Lomb | accessdata.fda.gov |
| October 16, 2008 | K082944 | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM | MSS | Substantially Equivalent | Bausch & Lomb, 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 |
| July 7, 2004 | K041608 | C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS | LPL | Substantially Equivalent | Unilens Corp., USA | accessdata.fda.gov |
| October 17, 2000 | K002408 | AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS | LPL | Substantially Equivalent | Unilens Corp., USA | accessdata.fda.gov |
| December 17, 1997 | K970727 | MPORT FOLDABLE LENS PLACEMENT SYSTEM | MSS | Substantially Equivalent | Chiron Vision Corp. | accessdata.fda.gov |
| April 10, 1996 | K960926 | POWER PLUS (POLYMACON) SOFT (HYDROPHILIC) ASPHERIC CONTACT LENS | LPL | Substantially Equivalent | Unilens Corp., USA | accessdata.fda.gov |
| July 7, 1994 | K942372 | SIMULVUE 38 (POLYMACON) SOFT (HYDROPHILIC) BIFOCAL CONTACT LENS | LPL | Substantially Equivalent | Unilens Corp., USA | accessdata.fda.gov |
| July 7, 1994 | K941836 | UNILENS 38 SOFT ASPHERIC CONTACT LENS | LPL | Substantially Equivalent | Unilens Corp., USA | accessdata.fda.gov |
| April 12, 1994 | K940777 | BAYVUE (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | Unilens Corp., USA | 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 |
| September 5, 2008 | P060022 | AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT | HQL | 35 | September 3, 2026 | 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 |
| 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 |
| September 28, 1989 | P890040 | SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS | LPM | 8 | February 29, 2016 | 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 |
| July 21, 1982 | P820005 | (POLYMACON) CONTACT LENSES | LPL | 5 | September 7, 1990 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 6, 2025 | 97232 | Class III | Ongoing | Akreos, SKU: AO60P0300. Akreos intraocular lenses | An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction. | accessdata.fda.gov |
| March 27, 2025 | 96594 | Class I | Ongoing | Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models start | In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S. | accessdata.fda.gov |
| November 7, 2020 | 86721 | Class II | Terminated | MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag. | Product may be missing toric axis marks. | accessdata.fda.gov |
| June 9, 2020 | 85862 | Class II | Terminated | enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and c | The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens. | accessdata.fda.gov |
| November 5, 2018 | 81600 | Class II | Terminated | enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended fo | Cosmetic imperfections on the surface of some lenses. | accessdata.fda.gov |
| April 5, 2017 | 77087 | Class II | Terminated | SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe s | Complaints concerning kinked haptics that were occurring during lens delivery. | accessdata.fda.gov |
| May 26, 2015 | 71411 | Class II | Terminated | Bausch & Lomb SofPort Advanced Optics Aspheric Lens | Haptics breaking during lens loading and insertion. | accessdata.fda.gov |
| October 16, 2013 | 67283 | Class II | Terminated | Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult pat | Lens was manufactured with incorrect raw material. | accessdata.fda.gov |
| February 27, 2004 | 29055 | Not yet classified | Terminated | SoFlex UV-Absorbing Model LI61U Silicone Posterior Chamber Intraocular Lens. | Lens may be labeled with incorrect diopter size. | accessdata.fda.gov |
Compare with other makers
- All makers of Folders And Injectors, Intraocular Lens (Iol)
- All makers of Lens, Guide, Intraocular
- All makers of Intraocular Lens
- All makers of Aid, Surgical, Viscoelastic
- All makers of Lens, Intraocular, Toric Optics
- All makers of Lens, Intraocular, Accommodative
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.