Clear CareRecalls & reported problems across all models
Alcon Laboratories, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Clear Care model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 1
We found 5 models of Clear Care by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Oct 8, 2020 and Dec 26, 2025 — classified as 11 injuries.
The most frequently reported specific device problem is “Improper Chemical Reaction” (3 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Clear Care recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 25, 2022Open, 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 Clear Care problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Improper Chemical Reaction3
- Improper or Incorrect Procedure or Method2
- Product Quality Problem2
- Use of Device Problem2
- Appropriate Device Problem Term/Code Not Available1
- Failure to Disinfect1
- Patient-Device Incompatibility1
Patient problems
- Blurred Vision7
- Eye Pain6
- Red Eye(s)6
- Corneal Abrasion5
- Excessive Tear Production5
- Eye Burn5
- Burning Sensation4
- Eye Irritation4
Clear Care models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Clear Care Clear Care 12ozAccessories, soft lens products1 recall0 reports
- Clear Care Clear Care 2x12ozAccessories, soft lens products4 reports
- Clear Care Clear Care 2x12ozAccessories, soft lens products4 reports
- Clear Care Clear Care 12ozAccessories, soft lens products2 reports
- Clear Care Clear Care 3ozAccessories, soft lens products1 report
Recent Clear Care adverse event reports
The 11 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 26, 2025Product Quality Problem; Improper Chemical Reaction; Appropriate Device Problem Term/Code Not Available; Product Quality Problem; Improper Chemical Reaction; Appropriate Device Problem Term/Code Not Available
AS INITIALLY REPORTED BY A NON-HEALTHCARE PROFESSIONAL, STATING THAT THE CONSUMER EXPERIENCED REPEATED CHEMICAL BURNS, EYE INJURY, SEVERE BURNING, AND DISCOMFORT AFTER WEARING CONTACT LENSES IN BOTH EYES, DESPITE STRICTLY FOLLOWING ALL DIRECTIONS FOR USE WITH THE LENS CARE SOLUTION. ALTHOUGH THE PRODUCT HAS BEEN TRUSTED FOR DECADES, THE CONSUMER STATED THAT RECENT FAILURES ARE UNACCEPTABLE AND DANGEROUS, NOTING THAT THE DISC DOES NOT FUNCTION PROPERLY AND THAT THESE ISSUES HAVE DISRUPTED DAILY ACTIVITIES. THE PROBLEM OCCURRED MULTIPLE TIMES ACROSS SEVERAL CASES. AT THE TIME OF REPORTING, NO MEDICAL INTERVENTION HAD BEEN SOUGHT. THE CURRENT STATUS OF THE CONSUMER¿S EYE WAS SYMPTOMS CONTINUING AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. UPON FOLLOW UP INFORMATION IT WAS REPORTED THAT CONSUMER EXPERIENCED ISSUES AFTER THE CHANGE IN THE NEW LENS CASE DESIGN.
Patient problems: Burning Sensation; Caustic/Chemical Burns; Eye Irritation
MAUDE report 23894751 ↗InjuryJul 23, 2025Improper Chemical Reaction; Improper Chemical Reaction
AS INITIALLY THE REPORTED BY THE CONSUMER STATING THAT THE CONSUMER EXPERIENCED SERIOUS EYE INJURY CAUSED BY THE CONTACT LENS SOLUTION EVEN AFTER FOLLOWING ALL INSTRUCTION AND NEUTRALIZING. THE CUSTOMER SUFFERED A CHEMICAL BURN TO THE EYE, WHICH LED TO A RUPTURED AND ONE MM MARGINAL CORNEAL ULCER IN THE LEFT EYE. THE INJURY REQUIRED MULTIPLE DOCTOR VISITS, PRESCRIPTIONS FOR ANTIBIOTIC AND STEROID EYE DROPS, AND WEEKS WITHOUT BEING ABLE TO WEAR CONTACT LENSES. CUSTOMER HAD TO WEAR GLASSES, WHICH IMPACTED THE VISION. THE CONTACT LENS CARE SUDDENLY STOPPED NEUTRALIZING PROPERLY WHICH RESULTED IN VISION PROBLEM IN ONE EYE. THE INJURY HAD RESULTED IN BLURRY VISION IN THE AFFECTED EYE ALONG WITH DISCOMFORT EVENT AFTER MEDICAL TREATMENT. DURING FOLLOW UP IT WAS ALSO DIAGNOSED TO HAVE CORNEAL KERATITIS. THE CURRENT STATUS OF THE CONSUMER'S EYE IS SYMPTOM RESOLVED AND THE CUSTOMER HAS RESUMED CONTACT LENS WEAR. NO ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Corneal Ulcer; Discomfort; Eye Burn; Eye Irritation; Eye Pain; Keratitis; Photophobia; Red Eye(s)
MAUDE report 22573552 ↗InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS INITIALLY REPORTED FROM ATTORNEY TO LEGAL TEAM ON BEHALF OF THE CONSUMER STATING THAT CONSUMER EXPERIENCED FOREIGN BODY SENSATION, BLURRED VISION, PAIN, PHOTOPHOBIA, AND RED EYE, WHICH WERE SEVERE IN NATURE IN RELATION TO THE RIGHT EYE (OD) FOR DURATION OF THREE WEEKS. CONSUMER SOUGHT MEDICAL ATTENTION FOR THE ABOVE SYMPTOMS. ON SLIT EXAMINATION OD HAD FOLLOWING FINDINGS GRANULAR KERATITIS (POORLY DEFINED WHITENING/ GREYING, NO WELL-DEFINED INFILTRATE) (1.2MM(V) X 2.0(H)) EPITHELIAL DEFECT. DIFFERENTIAL DIAGNOSIS OF HERPES SIMPLEX VIRUS, BACTERIAL, FUNGAL AND ACANTHAMOEBA WAS CONSIDERED. ADVISED FOR CORNEAL CULTURE AND CORNEAL PCR (POLYMERASE CHAIN REACTION) TESTS . DIAGNOSIS OF CENTRAL CORNEAL ULCER OF OD WAS PROVIDED FROM THE EYE CARE PROFESSIONAL (ECP).SHE WAS PRESCRIBED WITH MOXIFLOXACIN 0.5 % EYE DROPS, TO BE APPLIED ONE DROP IN THE RIGHT EYE EVERY TWO HOURS TILL NEXT VISIT, ERYTHROMYCIN 5 MG/GRAM (0.5 %) EYE OINTMENT, TO BE ADMINISTERED PEA-SIZED AMOUNT INTO RIGHT EYE THREE TIMES DAILY TILL NEXT VISIT., VALACYCLOVIR TABLET;1 GRAM, TO BE TAKEN ORALLY THREE TIMES DAILY TILL NEXT VISIT AND ADVISED FOR FOLLOW UP AFTER TWO DAYS FOR FURTHER EVALUATION AND MANAGEMENT . CONSUMER W
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Abrasion; Corneal Infiltrates; Corneal Ulcer; Erosion; Eye Irritation; Eye Pain; Infective Keratitis; Iritis; Photophobia; Ptosis; Purulent Discharge; Red Eye(s)
MAUDE report 20542404 ↗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 ↗InjuryJun 25, 2024Improper or Incorrect Procedure or Method; Improper Chemical Reaction; Improper or Incorrect Procedure or Method; Improper Chemical Reaction
AS INITIALLY REPORTED BY CONSUMER STATING THAT SHE BURNED THEIR RIGHT EYE EVEN AFTER USING THE CONTACT LENS CARE SOLUTION AS PER THE INSTRUCTIONS OF THE PRODUCT. CONSUMER ALSO HURT HER RIGHT EYE, TEARING AND EXPERIENCED RED EYES FOR TWO DAYS DUE TO NON-NEUTRALIZATION OF CONTACT LENS CARE SOLUTION EVEN THOUGH LENSES WERE KEPT IN CONTACT LENS CARE SOLUTION FOR TEN HOURS FOR NEUTRALIZATION. LATER DURING THE FOLLOW CONSUMER PROVIDED FURTHER INFORMATION STATING THAT HER RIGHT EYE DOES NOT HURT ANY MORE BUT HAS BLURRY VISION IN THE MIDDLE OF THE EYE DUE THE PREVIOUS BURN THAT HAPPENED FROM THE CONTACT LENS CARE SOLUTION. CONSUMER AGAIN DURING THE OTHER FOLLOW UP PROVIDED THE INFORMATION THAT THERE WAS SCARRING THAT IS PRESENT IN HER RIGHT EYE WHICH OBSTRUCTS HER VISION. CONSUMER HAS SCHEDULED APPOINTMENT WITH AN EYE SPECIALIST FOR THE SYMPTOMS. THE CURRENT EYE STATUS IS SYMPTOMS CONTINUING AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION CANNOT BE OBTAINED AS THE CONSUMER DOES NOT WANT TO BE CONTACTED AGAIN.
Patient problems: Blurred Vision; Caustic/Chemical Burns; Corneal Scar; Excessive Tear Production; Eye Burn; Eye Irritation; Eye Pain; Red Eye(s)
MAUDE report 19603226 ↗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 ↗InjuryApr 13, 2023Use of Device Problem; Use of Device Problem
NON HEALTH CARE PROFESSIONAL REPORTED ON BEHALF OF A CONSUMER, WHO EXPERIENCED SEVERE DAMAGE TO THE PUPIL, LOSS OF VISION IN LEFT EYE AND SIGNIFICANT DISTRESS AFTER USING CLEANING AND DISINFECTING SOLUTION. THE CONSUMER USED THE EXPIRED PRODUCTS. THE CURRENT STATUS OF THE CONSUMER'S EYE IS NOT RESOLVED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Patient problems: Corneal Abrasion; Distress; Loss of Vision
MAUDE report 16730703 ↗InjuryApr 13, 2023Use of Device Problem; Use of Device Problem
NON-HEALTH CARE PROFESSIONAL REPORTED ON BEHALF OF A CONSUMER, WHO EXPERIENCED SEVERE DAMAGE TO THE PUPIL, LOSS OF VISION IN LEFT EYE AND SIGNIFICANT DISTRESS AFTER USING CLEANING AND DISINFECTING SOLUTION. THE CONSUMER USED THE EXPIRED PRODUCTS. THE CURRENT STATUS OF THE CONSUMER'S EYE IS NOT RESOLVED AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.
Patient problems: Corneal Abrasion; Distress; Loss of Vision
MAUDE report 16730075 ↗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 ↗InjuryOct 8, 2020Patient-Device Incompatibility
CONSUMER CALLED TO REPORT THAT AFTER USING CLEAR CARE 3% HYDROGEN PEROXIDE CLEAN AND DISINFECTANT SOLUTION (OPHTHALMIC SOLUTION), SHE EXPERIENCED SEVERE EYE BURNING AND WATERY EYES. CONSUMER BELIEVES THAT THE DISC THAT IS SUPPOSED TO BE AT THE BOTTOM OF THE SOLUTION BOTTLE, DOES NOT LAST FOR THE DURATION OF THE PRODUCT, SO THE SOLUTION NO LONGER IS BEING NEUTRALIZED. CONSUMER HAS CONTACTED THE MANUFACTURER VIA EMAIL, AND HAS YET TO RECEIVE A RESPONSE. SHE HAS AUTHORIZED FDA TO PROVIDE HER NAME IN ORDER TO FACILITATE THE COMPLAINT FOLLOW-UP. EYE IRRITATION.
Patient problems: Burning Sensation; Excessive Tear Production; Irritation
MAUDE report 10658443 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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