Data / Medical devices / United States / Bausch & Lomb Incorporated
Bausch & Lomb Incorporated: FDA-registered device maker in Lancaster, NY, United States, 12 510(k) clearances
Bausch & Lomb Incorporated is registered with the FDA (registration 1315522) in Lancaster, NY, United States. It lists 3 device types. The FDA files 12 510(k) clearances under its listings, the newest dated November 17, 2023. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1315522
- Address
- 6 Lancaster Pkwy, Lancaster, NY, United States, 14086
- Owner or operator
- Bausch & Lomb Incorporated (1315522)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- July 29, 2001
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Inserter/Remover Contact Lens | KYE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Manufacturer | accessdata.fda.gov |
| Products, Contact Lens Care, Rigid Gas Permeable | MRC | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 17, 2023 | K230954 | Samfilcon B Custom Contact Lens | LPL | Substantially Equivalent | Bausch + Lomb, Incorporated | accessdata.fda.gov |
| April 26, 2011 | K102557 | NOVAKONE SPHERICAL AND TORIC LENSES | LPL | Substantially Equivalent | Alden Optical Labs., Inc. | accessdata.fda.gov |
| June 25, 2010 | K091327 | ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES | LPL | Substantially Equivalent | Alden Optical Labs., Inc. | accessdata.fda.gov |
| November 10, 2005 | K052703 | ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL | LPL | Substantially Equivalent | Alden Optical Labs., Inc. | accessdata.fda.gov |
| September 15, 2004 | K042242 | ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES | LPL | Substantially Equivalent | Alden Optical Labs., Inc. | accessdata.fda.gov |
| May 2, 2003 | K024289 | BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION | MRC | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| November 25, 1998 | K983278 | OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) | LPL | Substantially Equivalent | Alden Optical Labs., Inc. | accessdata.fda.gov |
| October 21, 1998 | K983053 | ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) | LPL | Substantially Equivalent | Alden Optical Labs., Inc. | accessdata.fda.gov |
| June 23, 1998 | K981252 | OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) | LPL | Substantially Equivalent | Alden Optical Labs., Inc. | accessdata.fda.gov |
| April 7, 1998 | K980554 | ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING) | LPL | Substantially Equivalent | Alden Optical Labs., Inc. | accessdata.fda.gov |
| December 8, 1997 | K973967 | AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) | LPL | Substantially Equivalent | Alden Optical Labs., Inc. | accessdata.fda.gov |
| May 17, 1978 | K780664 | SOFT LENS REMOVER/INSERTER/MANIPULATOR | KYE | Substantially Equivalent | Dmv Contact Lens Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 3, 2018 | 80800 | Class III | Terminated | Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curv | Vials labeled for the prescriptions contained incorrect lenses | accessdata.fda.gov |
| November 3, 2017 | 79377 | Class II | Terminated | NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (my | Contact lenses lack sterility assurance. | accessdata.fda.gov |
Compare with other makers
- All makers of Lenses, Soft Contact, Daily Wear
- All makers of Products, Contact Lens Care, Rigid Gas Permeable
- All makers of Inserter/Remover Contact Lens
Updated November 17, 2023. 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.