Clear Care Clear Care 2x12oz (UDI 00300650363402)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00300650363402), received between Dec 29, 2022 and Sep 18, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Disinfect” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Failure to Disinfect; Improper or Incorrect Procedure or Method; Failure to Disinfect; Improper or Incorrect Procedure or Method

  AS INITIALLY REPORTED BY THE GOVERNMENT AGENCY THAT THE CONSUMER USED THE EYE CARE SOLUTION TO CLEAN THE CONTACT LENSES AND EXPERIENCED BURNING OF BOTH THE CORNEAS AND BLURRY VISION. OTHER EVENTS WERE REPORTED STINGING AND TEARING FROM THE LEFT EYE. THE CONSUMER VISITED OPHTHALMOLOGIST AND TREATMENTS WERE PRESCRIBED TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION AND CONTACT BANDAGE FOR LEFT EYE AND ADVISED TO REVISIT NEXT DAY. CONSUMER REVISITED NEXT DAY AND OPHTHALMOLOGIST REMOVED CONTACT BANDAGE FROM THE LEFT EYE AND INSTRUCTED TO CONTINUE TO USE THE EYE DROPS FOR A WEEK INSTILLING ONE DROP IN BOTH THE EYES FOR EVERY SIX HOURS. THE CURRENT STATUS OF THE EYES ARE SYMPTOMS WERE IMPROVING AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. ADDITIONAL INFORMATION HAVE BEEN RECEIVED WHICH STATES THAT THE CONSUMER ARE NOT USING THE PRODUCT AS PER THE DIRECTIONS AND MISSING WITH THE PRE RINSING PART MENTIONED IN THE DIRECTION OF USE AND THE CURRENT CONSUMER EYE CONDITION WAS RESOLVED.

  Patient problems: Blurred Vision; Burning Sensation; Excessive Tear Production; Eye Burn

  MAUDE report 20246237 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED ON BEHALF OF A CONSUMER THAT THE CONSUMER EXPERIENCE LACRIMATION, SENSATION OF SCRATCH SENSATION, RED EYES, EYE PAIN, DISCHARGE, DRY EYE, BLURRY VISION, BURNING IN BOTH EYES. THE CONSUMER VISITED DOCTOR AND DIAGNOSED WITH PHOTOTOXICITY. THE CONSUMER WAS PRESCRIBED WITH UNSPECIFIED ANTIBIOTICS. THE CURRENT STATUS OF THE CONSUMER¿S EYE WAS RESOLVED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Burning Sensation; Dry Eye(s); Excessive Tear Production; Eye Pain; Foreign Body Sensation in Eye; Phototoxicity; Red Eye(s)

  MAUDE report 18022377 ↗
• InjurySep 22, 2023Product Quality Problem; Product Quality Problem

  SAFETY EVENT DESCRIPTION: A CONSUMER EXPERIENCED CONSUMER STATING SHE EXPERIENCED BLURRY VISION, DRY EYE, EYE PAIN, LENS BECAME HARD, RED EYES, CORNEAL ABRASION, DISCOMFORT MADE NOSE CONSTANTLY RUN AND SOUND SICK AND TEARING. ADDITIONAL INFORMATION RECEIVED WITH MEDICAL RECORD STATES THAT THE CONSUMER VISITED DOCTOR AND UNDERWENT EYE EXAMINATION IN WHICH CONSUMER¿S LID MARGIN, ANTERIOR CHAMBER, IRIS, AND LENS WERE NORMAL FOR BOTH EYES. CONJUNCTIVA AND CORNEA WERE NORMAL FOR LEFT EYE. BUT IN RIGHT EYE THE CONSUMER GOT DIAGNOSED WITH CENTRAL RECURRENT CORNEAL EROSION. THE CONSUMER WAS PRESCRIBED WITH MOXIFLOXACIN OPHTHALMIC SOLUTION 0.5% WITH A FREQUENCY OF EVERY HOUR WHILE AWAKE, CARBOXY METHYL CELLULOSE SODIUM EYE DROPS WITH A FREQUENCY OF EVERY NIGHT AT BEDTIME AND SYSTANE COMPLETE EYE DROPS WITH A FREQUENCY OF ONCE IN A DAY IN THE MORNING. THE CONSUMER WAS SUGGESTED TO SCHEDULE A FOLLOW-UP VISIT. THE CONSUMER VISITS ANOTHER DOCTOR AS A FOLLOW-UP VISIT. THE CONSUMER AGAIN UNDERWENT EYE EXAMINATION IN WHICH LID MARGIN, ANTERIOR CHAMBER, IRIS, CONJUNCTIVA, AND LENS WERE NORMAL FOR BOTH EYES. THE DIAGNOSTIC DROPS USED WERE FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE CORNEAL EXAMI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Abrasion; Dry Eye(s); Excessive Tear Production; Eye Burn; Eye Pain; Foreign Body Sensation in Eye; Hypersensitivity/Allergic reaction; Keratitis; Red Eye(s); Vitreous Floaters

  MAUDE report 17797378 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS INITIALLY REPORTED BY CONSUMER STATING THAT SHE PUT HER LENSES AFTER SOAKING THEM IN THE SOLUTION FOR ONE DAY, EXPERIENCED FOGGY VISION AND THE SYMPTOM DID NOT RESOLVED AFTER REMOVING CONTACT LENSES. AFTER THAT SHE EXPERIENCED EXCRUCIATING PAIN AND WENT TO EMERGENCY DEPARTMENT AND WAS DIAGNOSED WITH BILATERAL CHEMICAL CORNEAL ABRASIONS. EYES WERE IRRIGATED. THE BURNS WERE SO BAD, THEY RECOMMENDED TO SHIFT TO OTHER HOSPITAL FOR FURTHER EVALUATIONS. FURTHER INFORMATION RECEIVED ON 11/DEC/2022 STATES THAT THE CONSUMER WENT TO EMERGENCY DEPARTMENT WITH BILATERAL EYE PAIN ASSOCIATED WITH PHOTOPHOBIA AND TEARING. THE CONSUMER WAS POSITIVE FOR PAIN, REDNESS AND ITCHING. FLUORESCEIN TEST WAS DONE ON BOTH EYES RESULTING IN APPROXIMATELY 5 TO 6 MM OVER THE CENTRAL VISUAL FIELD FOR RIGHT EYE. CONSUMER WAS DIAGNOSED WITH BILATERAL CORNEAL ABRASIONS AND CORNEAL ULCER. BILATERAL EYE IRRIGATIONS WERE DONE AND DISCHARGED WITH ANTIBIOTICS. ERYTHROMYCIN 5 MG/GM OPHTHALMIC OINTMENT, OFLOXACIN 0.3% OPHTHALMIC DROPS, ALBUTEROL HFA 108 (90 BASE) MCG/ACT INHALER, AMPHETAMINE/DEXTROAMPHETAMINE 5 AND 10 MG TABLET, CETIRIZINE 10 MG TABLET, LORATADINE 10 MG TABLET, NITROFURANTOIN MACROCRYSTAL 50 MG CAPSUL

  Patient problems: Blurred Vision; Corneal Abrasion; Corneal Ulcer; Eye Burn; Eye Pain; Itching Sensation; Overwear Syndrome; Red Eye(s)

  MAUDE report 16069116 ↗