COMPLETE 93506LCAHZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827444000638), received between Jan 30, 2017 and Aug 19, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  WHILE CONDUCTING A SEARCH OF THE MAUDE ADVERSE EVENTS DATABASE, THIS REPORT WAS IDENTIFIED. THE REPORT IS A CORNEAL ULCER BY PSEUDOMONAS IN PATIENT'S RIGHT EYE, FOLLOWED THREE WEEKS LATER BY PSEUDOMONAS OLEAGINOUS AND CORNEAL ULCER LEFT EYE. COMPLETE MULTIPURPOSE SOLUTION WAS SENT FOR CULTURES, GREW PSEUDOMONAS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Corneal Ulcer; Eye Infections

  MAUDE report 12344777 ↗
• InjuryJul 30, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CONSUMER REPORTED USING COMPLETE EASY RUB MULTIPURPOSE SOLUTION TO SOAK AND CLEAN HIS LENSES. WHEN HE TOOK THE CONTACT OUT OF THE SOLUTION AND PLACED IT IN HIS EYE HE EXPERIENCED SEVERE BURNING. CONSUMER ALSO REPORTS HE PASSED OUT AND BROKE TWO (2) TEETH. HE WENT TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL FOR THREE DAYS. HE HAD TWO MAGNETIC RESONANCE IMAGE (MRI) AND 3 CAT SCANS. HE STATED HIS DOCTORS NOTED THAT THE SOLUTION HAD SOME SORT OF PARASITE OR SOMETHING AND HE HAD A VIRAL INFECTION. HE WAS PRESCRIBED MEDICATIONS AND WILL CONTINUE TO SEE HIS DOCTOR. FURTHER DETAILS WERE PROVIDED BY THE CONSUMER WHO REITERATED HIS EXPERIENCE. HE OPENED THE BOTTLE OF COMPLETE AND STORED HIS CONTACT LENSES IN THE SOLUTION OVERNIGHT. THE NEXT MORNING, HE PLACED A CONTACT LENS IN HIS RIGHT EYE AND IMMEDIATELY EXPERIENCED SEVERE BURNING, HIS EYE BECAME RED AND SWELLED SHUT. HE DID NOT ATTEMPT TO PUT IN HIS LEFT CONTACT LENS. HE SAID THE DOCTORS PERFORMED MANY TESTS INCLUDING MRI AND CT SCANS BUT FOUND NOTHING. WHEN HE TOLD THE PHYSICIAN, WHAT HAPPENED HE SAID HE WAS TOLD THAT IT IS VERY RARE, BUT SOMETHING PARASITIC COULD HAVE BEEN IN THE SOLUTION AND HE WAS DIAGNOSED WITH A BACTERIAL

  Patient problems: Burning Sensation; Dizziness; Intraocular Infection

  MAUDE report 7730350 ↗
• InjuryJan 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE CONSUMER REPORTED THAT HE HAD RECENTLY PURCHASED COMPLETE AND EXPERIENCED REDNESS AND AN INFECTION. IN FOLLOW UP WITH THE CONSUMER, HE REPORTED THAT HE STARTED TO USE SOLUTION ON (B)(6) AND USED IT FOR THREE DAYS AND STOPPED ON (B)(6) 2016. THIS WAS THE FIRST TIME HE HAD USED THE PRODUCT. HE FOLLOWED THE CLEANING REGIMEN AND STOPPED USING PRODUCT AFTER REDNESS STARTED. PRIOR TO USING COMPLETE, PATIENT USED RENU MULTI-PURPOSE SOLUTION. PATIENT DID GO TO THE DOCTOR AND HE WAS TOLD THAT HIS EYES WERE ALLERGIC TO SOMETHING. HE WAS PRESCRIBED 2 DIFFERENT EYE DROPS: PAZEO (OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION) 0.7% AND MOXEZA (MOXIFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION) 0.5% AS BASE. PATIENT ALSO SAID HIS EYES HAD FULLY RECOVERED AT THE TIME OF THE CALL. FURTHER FOLLOW UP WITH THE CONSUMER REPORTS THE REDNESS STARTED AROUND THE AFTERNOON OF (B)(6) , BUT IT WAS NOT TOO SERIOUS. CONSUMER SAID HIS RIGHT EYE BECAME REALLY RED THE NEXT DAY, SO HE BECAME WORRIED. HE WAS PRESCRIBED MOXEZA TO BE TAKEN 2 TIMES A DAY AND PAZEO TO BE TAKEN 1 TIME A DAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Red Eye(s)

  MAUDE report 6285604 ↗