OPTI-FREE PUREMOIST OPTI-FREE PUREMOIST 10ozRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00300650361040), received between Aug 25, 2023 and Nov 3, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Emits Odor” (2 reports).

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 3, 2023Device Emits Odor; Device Emits Odor

  ON 30/NOV/2023, ADDITIONAL INFORMATION HAS BEEN RECEIVED STATES THAT CONSUMER WAS TREATED WITH MOXIFLOXACIN 0.5%, 3ML OPHTHALMIC SOLUTION AND PREDNISONE 1% 15ML OPHTHALMIC SUSPENSION EYE DROPS FOR THE EYE INFECTION. ADDITIONALLY, THE CONSUMER WAS TREATED WITH PREDNISONE 20MG TABLETS, KETOCONAZOLE 2% SHAMPOO 120ML, CIPROFLOXACIN 500MG TABLET, AND TRIAMCINOLONE 0.1% OINTMENT 80GM FOR SINUS AND SKIN RASHES. THE CURRENT CONDITION OF CONSUMER'S EYE IS SYMPTOMS RESOLVED, WITH THE AVAILABLE INFORMATION THE CASE STILL RETAIN AS SERIOUS AND REPORTABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Conjunctivitis; Eye Pain; Foreign Body Sensation in Eye; Fungal Infection; Headache; Hemorrhage/Blood Loss/Bleeding; Rash

  MAUDE report 18065296 ↗
• InjuryAug 25, 2023Device Emits Odor; Device Emits Odor

  INITIALLY RECEIVED FROM CONSUMER STATING THAT THE CONSUMER EXPERIENCED PUS, DRY EYE, BURNING, BLURRY VISION, SOLUTION SMELLED DIFFERENT, IRRITATION, TEARING, REDEYES AND EYE PAIN. FUNGAL INFECTION WAS THE DIAGNOSIS AND EYE DROPS WERE TAKEN. CURRENT PATIENT'S CONDITION IS SYMPTOMS CONTINUING. ADDITIONAL INFO HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Dry Eye(s); Excessive Tear Production; Eye Burn; Eye Pain; Foreign Body Sensation in Eye; Fungal Infection; Purulent Discharge; Red Eye(s)

  MAUDE report 17624608 ↗