OPTI-FREE REPLENISH OPTI-FREE REPLENISH 10ozRecalls & reported problems
Alcon Laboratories, Inc. · Opti-Free Replenish Multi-Purpose Disinfecting Solution 10 oz. · Class 2
All models of OPTI-FREE REPLENISH (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00300650356107), received between Apr 16, 2024 and Apr 16, 2024 — classified as 1 injury.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- May 25, 2022Class IIOpen, Classified
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 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Corneal Ulcer1
- Eye Pain1
- Foreign Body Sensation in Eye1
- Red Eye(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL ON BEHALF OF CUSTOMER REPORTED THAT CONSUMER EXPERIENCED EYE REDNESS AND DEVELOPED CORNEAL ULCER IN RIGHT EYE. THE CONSUMER ALSO HAD EYE PAIN AND EYE WAS BOTHERING LIKE A SHARP NEEDLE STABBING. THE CONSUMER SOUGHT MEDICAL ATTENTION. THE CONSUMER WAS TREATED WITH MOXIFLOXACIN 0.5% OPHTHALMIC SOLUTION 3ML (1 DROP 6 TIMES A DAY). THE CURRENT STATUS OF THE CONSUMER¿S EYE IS RESOLVED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Patient problems: Corneal Ulcer; Eye Pain; Foreign Body Sensation in Eye; Red Eye(s)
MAUDE report 19119020 ↗
Other Accessories, soft lens products devices
- Clear Care Clear Care 12ozAlcon Laboratories, Inc. · Accessories, soft lens products1 recall0 reports
- OPTI-FREE REPLENISH OPTI-FREE REPLENISH 2ozAlcon Laboratories, Inc. · Accessories, soft lens products1 recall0 reports
- OPTI-FREE REPLENISH OPTI-FREE REPLENISH 4ozAlcon Laboratories, Inc. · Accessories, soft lens products1 recall0 reports
- REFRESH CONTACTS® Contact Lens Comfort Drops 91822USAllergan, Inc. · Accessories, Soft Lens Products1 recall0 reports
- Clear Care Clear Care 2x12ozAlcon Laboratories, Inc. · Accessories, soft lens products4 reports
- Clear Care Clear Care 2x12ozAlcon Laboratories, Inc. · Accessories, soft lens products4 reports
- COMPLETE 93504LCAHZJohnson & Johnson Surgical Vision, Inc. · Accessories, soft lens products4 reports
- COMPLETE 93506LCAHZJohnson & Johnson Surgical Vision, Inc. · Accessories, soft lens products3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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