Accessories, Soft Lens Products
Ophthalmic · 21 CFR 886.5928
Recent MDR events
8,031 adverse event reports on file
- Clear Care Plus with HydraGlyde Contact Lens SolutionJul 30, 2026OtherMW6000173
- Clear Care 3% Hydrogen Peroxide SolutionJul 21, 2026OtherMW6000099
- AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTIONJul 20, 2026InjuryAlcon Research, Llc1610287-2026-00036
- OPTIFREE PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTION 5-IN-1Jul 8, 2026MalfunctionAlcon Research, LlcMW5190450
- CLEAR CARE CONTACT LENS CLEANING SOLUTIONJul 8, 2026InjuryAlcon Research, LlcMW5190452
- CLEAR CARE 3% HYDROGEN PEROXIDE TRIPLE ACTION CLEANINGJul 1, 2026MalfunctionAlcon Research, Llc.MW5190180
- AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTIONJun 23, 2026InjuryAlcon Research, Llc1610287-2026-00034
- AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTIONJun 16, 2026InjuryAlcon Research, Llc1610287-2026-00033
- OPTI-FREE PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTIONJun 11, 2026InjuryAlcon Research, Llc1610287-2026-00029
- OPTI-FREE PUREMOIST MULTI-PURPOSE DISINFECTING SOLUTIONMay 29, 2026InjuryAlcon Research, Llc1610287-2026-00026
Event type breakdown
Recalls
23 recall events for this product code
- Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1590-2022 · View FDA record ↗ - Family Dollar Stores, Llc.Open, ClassifiedAug 17, 2022
B L BIOTRU MULTI PURPOSE SOLUTION 4 FLOZ, SKU 999009
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Z-1531-2022 · View FDA record ↗ - Family Dollar Stores, Llc.Open, ClassifiedAug 17, 2022
CLEAR EYES CONTCT LENS DRPS LBRCTNG .5FO, SKU 900531
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Z-1533-2022 · View FDA record ↗ - Family Dollar Stores, Llc.Open, ClassifiedAug 17, 2022
OPTI FREE REPLENISH MULTI PURPOSE 2 OZ
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
Z-1540-2022 · View FDA record ↗ - Marietta VisionTerminatedMar 4, 2011
AquaRefresh, Multi-Purpose Solution, 2 fl.oz/60mL, Made in the Netherlands, Distributed by Marietta Vision, 397 N. Sessions Street, Marietta, GA 30060.
Product is misbranded; Product labeled as, Made in the Netherlands, was actually manufactured in Mexico.
Z-1557-2011 · View FDA record ↗ - Abbott Medical Optics Inc (AMO)TerminatedNov 2, 2010
AMO COMPLETE Multi-Purpose Solution, Formula: 9424x; Product Code: 93504 (360ml), 93505 (2x 360ml duo pack), 93515 (240 ml).
The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening.
Z-0129-2011 · View FDA record ↗ - Abbott Medical Optics Inc (AMO)TerminatedNov 2, 2010
AMO Total Care (1) Contact Lens Solution, Formula: 8772x; Product Code: 90275 (240 ml).
The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the sterility of the product may be compromised. Products that are non-sterile have the potential to cause eye infections, which may be sight threatening.
Z-0130-2011 · View FDA record ↗ - Bausch & Lomb IncTerminatedNov 10, 2009
Bausch & Lomb ReNu Multi-Purpose Solution, 12 fl.oz. (355 ml), Bausch & Lomb, Incorporated, Rochester, NY 14609.
During routine testing the product failed to meet shelf life specifications.
Z-0159-2010 · View FDA record ↗ - Bausch & Lomb IncTerminatedAug 13, 2009
Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Bausch & Lomb Incorporated, Rochester,
The product failed to meet one of the shelf life specifications at the end of the expiry period.
Z-1735-2009 · View FDA record ↗ - Advanced Medical Optics, Inc.TerminatedJul 19, 2007
COMPLETE MOISTUREPLUS MULTIPURPOSE SOLUTION, Formula 9451X;
In response to information received 05/25/2007 from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections. CDC estimates a risk of at least seven times greater for those who use Complete MoisturePlus solution versus those who did not.
Z-1092-2007 · View FDA record ↗
Registered firms
108 firms currently registered for this product code
Bausch & Lomb Incorporated
Rochester, NY, US
Alcon Research, Llc
Fort Worth, TX, US
Johnson & Johnson Surgical Vision, Inc.
Irvine, CA, US
Westrock Converting, Llc
BOLINGBROOK, IL, US
Menicon Co., Ltd., R&d Center
Kasugai Aichi, JP
Amo (hangzhou) Co., Ltd.
HANGZHOU Zhejiang, CN
K. C. Pharmaceuticals, Inc.
POMONA, CA, US
Amo (hangzhou Park) Warehouse
Hangzhou Zhejiang, CN
Bausch & Lomb Incorporated
GREENVILLE, SC, US
Menicon Co. Ltd.
NAGOYA Aichi, JP
Allergan Sales, Llc
IRVINE, CA, US
Global Packaging Systems Inc
Fort Worth, TX, US
Altaire Pharmaceuticals, Inc.
AQUEBOGUE, NY, US
510(k) clearances
120 clearances for this product code
- Bausch & Lomb, IncorporatedDec 6, 2022
K222541 · Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
- Chemtex USA, Inc.Oct 12, 2022
K221263 · Aqua Naina Plus Sterile Saline Solution
- Bausch & Lomb, IncorporatedMay 28, 2021
K202932 · ABT12 multi-purpose solution
- Ote North America, LLCMay 26, 2021
K210051 · OTE MPS 045 Multi-purpose Lens Care Solution
- Chemtex USA, Inc.May 26, 2020
K193441 · Aqua Naina Sterile Saline Solution
- The Lifestyle Company, Inc.May 15, 2020
K200747 · PuriLens Plus Preservative Free Saline
- Menicon Co, Ltd.Mar 2, 2020
K191872 · Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution
- Allergan, Inc.Aug 8, 2019
K190674 · REFRESH RELIEVA For CONTACTS
PMA approvals
2 premarket approvals for this product code