Accessories, Solution, Ultrasonic Cleaners For Lenses
Ophthalmic · 21 CFR 886.5928
Recent MDR events
324 adverse event reports on file
- CLEAR CARE CLEANING & DISINFECTING SOLUTIONApr 8, 2026InjuryBausch & Lomb IncorporatedMW5186458
- CLEAR CARE CLEANING & DISINFECTING SOLUTIONApr 8, 2026InjuryBausch & Lomb IncorporatedMW5186459
- BIOTRUE MULTI-PURPOSE SOLUTIONOct 20, 2025InjuryBausch & Lomb Incorporated0001313525-2025-00193
- BIOTRUE MULTI-PURPOSE SOLUTIONOct 10, 2025InjuryBausch & Lomb Incorporated0001313525-2025-00188
- BOSTON ADVANCE CONDITIONING SOLUTIONMar 19, 2025InjuryBausch & Lomb Incorporated0001313525-2025-00032
- CONTACT LENSE SOLUTION BIO TRUE MULTI-PURPOSE SOLUTIONFeb 18, 2025InjuryBausch And Lomb IncorporatedMW5166209
- RENU ADVANCED CONTACT LENS SOLUTIONNov 27, 2024MalfunctionBausch & Lomb IncorporatedMW5162948
- RENU ADVANCED CONTACT LENS SOLUTIONNov 27, 2024MalfunctionBausch & Lomb IncorporatedMW5162949
- EQUATE LENS CLEANERNov 15, 2024OtherWal-mart StoresMW5162551
- BIOTRUE MULTI-PURPOSE SOLUTIONOct 24, 2024InjuryBausch & Lomb Incorporated0001313525-2024-00164
Event type breakdown
Recalls
14 recall events for this product code
- Family Dollar Stores, Llc.Open, ClassifiedNov 7, 2023
MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935
Products were stored outside of labeled temperature requirements.
Z-0269-2024 · View FDA record ↗ - Bausch & Lomb Inc- Greenville Solutions PlantTerminatedOct 24, 2014
Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc.
Product lot did not meet the specification for its disinfectants at the time of manufacture.
Z-0126-2015 · View FDA record ↗ - Bausch & Lomb Inc- Greenville Solutions PlantTerminatedMay 6, 2014
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
Out of specification results for one of the two disinfectants.
Z-1554-2014 · View FDA record ↗ - Bausch & Lomb IncTerminatedAug 19, 2011
Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716
Muti-purpose solution bottles, lot GC1107 were packaged in a carton that was marked with an incorrect lot code and expiration date.
Z-3042-2011 · View FDA record ↗ - Bausch & Lomb IncTerminatedFeb 2, 2011
Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb Place, Rochester, NY 14609
There is a potential for some packages to not meet sterility requirements.
Z-1025-2011 · View FDA record ↗ - Bausch & Lomb IncTerminatedFeb 2, 2011
Up&Up Multipurpose Solution, no-rub formula, 12 FL OZ (355 mL), Sterile, Distributed by Target Corporation, Minneapolis, MN 55403
There is a potential for some packages to not meet sterility requirements.
Z-1026-2011 · View FDA record ↗ - K C Pharmaceuticals IncTerminatedApr 2, 2010
Publix Sterile Preserved Saline Solution 12oz, Product SKU#041415-003767.
The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
Z-1222-2010 · View FDA record ↗ - K C Pharmaceuticals IncTerminatedApr 2, 2010
Top Care Sterile Preserved Saline Solution 12oz, Product SKU#0036800-16040.
The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
Z-1223-2010 · View FDA record ↗ - K C Pharmaceuticals IncTerminatedApr 2, 2010
Safeway Sterile Preserved Saline Solution 12oz, Product SKU#321130-700707.
The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
Z-1224-2010 · View FDA record ↗ - K C Pharmaceuticals IncTerminatedApr 2, 2010
Hannaford Sterile Preserved Saline Solution 12oz, Product SKU#041268-029297.
The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination and may not be sterile.
Z-1225-2010 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
22 clearances for this product code
- Suzhou 3N Biological Technology Co., Ltd.Jan 13, 2022
K211361 · 3N Contact Lenses Adjunct Cleaner
- Vuesonic, LLCApr 1, 2021
K210300 · VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
- Bausch & Lomb, Inc.Nov 18, 2009
K083757 · BPZ02 MULTIPURPOSE SOLUTION
- Autolens, Inc.Dec 16, 2002
K021699 · AUTOLENS CLEANING AND DISINFECTING UNIT
- Ciba Vision CorporationNov 19, 2002
K022687 · AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
- Bausch & Lomb, IncorporatedMay 31, 2002
K020802 · RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
- Strieter Clinical Research Laboratories, Inc.Feb 22, 2000
K994021 · CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
- Purilens, Inc.Oct 1, 1999
K991965 · PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES