# Bausch & Lomb, Inc.

- Location (FDA's records): Rochester, NY
- FDA decisions: 163 (1971–2026): 132 510(k) clearances and 31 original PMA approvals
- Names in FDA's records: Bausch & Lomb, Inc. (114); Bausch & Lomb, Incorporated (24); Bausch & Lomb (18); Bausch + Lomb, Incorporated (4); Bausch+Lomb (2); Bausch + Lomb, Inc. (1)
- Product codes: LPL (21), LPN (20), HQL (16), HQC (11), MSS (11), HQD (8), LPM (6), JJQ (6), HPX (5), MRC (4), HNO (4), HJO (4)
- 510(k) review time since 2016: median 92 days, against 88 for FDA's reviews in the same codes and years (6 of 15 faster)
- Predicates its devices cite: 126 (74 its own); citations of its devices by later devices: 142 (74 its own)
- Recalls linked to its devices: 74 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Storz Instrument Co.: 7 (https://510kreport.com/company/storz-instrument)
- Ciba Vision Corporation: 6 (https://510kreport.com/company/ciba-vision)
- Polymer Technology Corp.: 6 (https://510kreport.com/company/polymer-technology)
- Chiron Vision Corp.: 3 (https://510kreport.com/company/chiron-vision)
- Alcon Laboratories: 3 (https://510kreport.com/company/alcon-laboratories)
- Alcon Manufacturing, Ltd.: 2 (https://510kreport.com/company/alcon-manufacturing)
- Advanced Medical Optics, Inc.: 2 (https://510kreport.com/company/advanced-medical-optics)
- Allergan, Inc.: 2 (https://510kreport.com/company/allergan)

## Firms that cite its devices most
- Menicon Co, Ltd.: 6 (https://510kreport.com/company/menicon)
- Acuity Polymers, Inc.: 5 (https://510kreport.com/company/acuity-polymers)
- Alcon Laboratories: 5 (https://510kreport.com/company/alcon-laboratories)
- Bausch and Lomb, Incorporated: 5 (https://510kreport.com/company/bausch-and-lomb)
- Contamac, Ltd.: 3 (https://510kreport.com/company/contamac)
- Alcon Research, Ltd.: 3 (https://510kreport.com/company/alcon-research)
- Paragon Vision Sciences: 3 (https://510kreport.com/company/paragon-vision-sciences)
- E&E Optics, Inc.: 2 (https://510kreport.com/company/e-e-optics)

## Its most-cited devices
- K053124: Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses (2006), cited by 8
- K131208: Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon a) Contact Lens for Presbyopia, (2013), cited by 6
- K071266: Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens (2007), cited by 6
- K071043: Boston XO (Hexafocon a), Boston EO (Enflufocon B)  and Boston ES (Enflufocon a) Rigid Gas Permeable Contact Lenses (2007), cited by 5
- K113852: Bausch & Lomb Iol Injector (2012), cited by 5
- K171404: BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) (2017), cited by 5

## Recent decisions
- K262941: Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (Oct 16, 2026)
- K242389: EyeGility™ Inserter for Preloaded enVista IOLs (Oct 10, 2024)
- P240005: enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (Oct 10, 2024)
- K230954: Samfilcon B Custom Contact Lens (Nov 17, 2023)
- K220613: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Mar 8, 2023)
- K222541: Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (Dec 6, 2022)
- K211786: Independent Corneal Viewing Chamber (IVC-21) (Dec 3, 2021)
- K202932: ABT12 multi-purpose solution (May 28, 2021)

Source page: https://510kreport.com/company/bausch-lomb