OPTI-FREE PUREMOIST OPTI-FREE PUREMOIST 4ozRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00300650361033), received between Oct 8, 2021 and Nov 20, 2024 — classified as 2 injuries.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INITIALLY REPORTED BY A NON-HEALTH CARE PROFESSIONAL WHO EXPERIENCED CHEMICAL BURNS TO THE CORNEA IMMEDIATELY UPON USE AND WAS UNABLE TO SEE CLEARLY FOR SEVERAL DAYS. THE CONSUMER REQUIRED EMERGENCY CARE FOR TWO TIMES, AND UPON FOLLOW UP WITH OPHTHALMOLOGIST CONSUMER WAS DIAGNOSED AS BILATERAL EYE IRRITATION. CONSUMER WAS PRESCRIBED WITH CONJUNCTIVAL INJECTION, DEXAMETHASONE, FLUORESCEIN, DIPHENHYDRAMINE, OXYCODONE HYDROCHLORIDE, ALCAINE. THE USE OF THE PRODUCT WAS DISCONTINUED. THE CURRENT STATUS OF THE CONSUMER'S EYE WAS UNKNOWN AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Blurred Vision; Eye Burn; Eye Irritation

  MAUDE report 20735354 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORTER INFORMED THAT A CONSUMER EXPERIENCED BURNS TO HER EYES AFTER USING MULTI-PURPOSE DISINFECTING SOLUTION FOR SOME CONTACT LENSES AFTER FOLLOWING THE DIRECTIONS ON THE OF THE SOLUTIONS BOTTLE THE CONSUMER PLACED THE CONTACT LENSES ON THE EYES AND BEGAN TO EXPERIENCE BURNING. THE CONSUMER REMOVED THE CONTACT LENSES, HOWEVER, THE BURNING CONTINUED RESULTING IN RED EYES, BLURRED VISION, TEMPORARY LOSS OF VISION IN THE RIGHT EYE AND DECREASE IN VISION IN THE LEFT EYE, WITH TEARING AND PHOTOPHOBIA. THE CONSUMER SOUGHT TREATMENT AND DIAGNOSED WITH A CORNEA BURN, CORNEA EROSION AND CORNEL ABRASION IN THE RIGHT EYE, AND KERATITIS IN THE LEFT EYE CORNEA. THE CONSUMER WAS TREATED WITH A BANDAGE/THERAPEUTIC CONTACT LENS, PRESSURE PATCH, ERYTHROMYCIN, PROPARACAINE, OFLOXACIN AND BESIFLOXACIN. THE REPORTER INFORMED THAT THE CONSUMERS EYESIGHT SEEMS TO HAVE RETURNED TO NORMAL. A PRODUCT SAMPLE HAS BEEN REQUESTED FOR EVALUATION FOR THIS EVENT. NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Blurred Vision; Corneal Abrasion; Excessive Tear Production; Eye Burn; Eye Pain; Keratitis; Loss of Vision; Red Eye(s)

  MAUDE report 12596662 ↗