renu sensitive multi-purpose solution FCP-4836BRecalls & reported problems
Bausch & Lomb Incorporated · Soft Contact Lens Disinfecting Solution, 4 FL OZ · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00310119030486), received between Feb 22, 2017 and Feb 22, 2017 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- Burning Sensation1
- Eye Burn1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ATTORNEY REPRESENTING A CONSUMER PROVIDED A SUMMARY STATEMENT ASSOCIATED WITH A MEDICAL EVENT. ON (B)(6) 2016, THE CONSUMER WAS REPORTED TO HAVE PURCHASED THE PRODUCT. THAT NIGHT, THE CONSUMER WAS REPORTED TO REMOVE HIS LENSES AND PUT THEM INTO A CONTACT CASE CONTAINING THE PRODUCT. THE CONSUMER LEFT HIS CONTACTS TO SOAK IN THE SOLUTION, AND THEN HE WAS REPORTED TO HAVE PUT THEM BACK IN ON (B)(6) 2016. UPON PUTTING THE CONTACTS IN, THE CUSTOMER WAS REPORTED TO HAVE FELT AN INSTANT BURNING SENSATION THAT HE ATTRIBUTED TO THE NEW SOLUTION. THE CONSUMER INDICATED THE BURNING SUBSIDED ABOUT 20 MINUTES LATER. THROUGHOUT THE DAY, THE CONSUMER WAS REPORTED TO RECALL HIS VISION BEING "CLOUDY" OR "SMOKY". THE CONSUMER CALLED AND MADE AN APPOINTMENT WITH AN OPTOMETRIST FOR A ROUTINE EYE APPOINTMENT AS HE WAS DUE ANYWAY. THE APPOINTMENT WAS SET FOR (B)(6) 2016. THE CONSUMER WAS REPORTED TO HAVE PROCEEDED THROUGH THE DAY WITH THE IRRITATION TO HIS EYES SOMEWHAT SUBSIDING BUT STILL PRESENT. THE NEXT MORNING, (B)(6) 2016, THE EYES WERE REPORTED TO STILL BOTHER THE CONSUMER, SO HE TOOK OUT HIS CONTACTS. UPON DOING SO, THE BURNING SENSATION WAS REPORTED TO RETURN WITH GREATER INTENSITY. AT THE
Patient problems: Blurred Vision; Burning Sensation; Eye Burn; Pain
MAUDE report 6350287 ↗
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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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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