COMPLETE 93504LCAHZRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · COMPLETE MPS 360ML+LENS CASE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827444000614), received between Oct 26, 2017 and Jul 13, 2020 — classified as 4 injuries.
The most frequently reported specific device problem is “Contamination” (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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Contamination1
Patient problems
- Burning Sensation2
- Irritation2
- Red Eye(s)2
- Blurred Vision1
- Conjunctivitis1
- Dry Eye(s)1
- No Code Available1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FEMALE CONSUMER REPORTED USING MULTIPURPOSE SOLUTION EASY RUB FORMULA (EASY RUB) AFTER BEING GIVEN THE PRODUCT FROM A FRIEND. THE CONSUMER TRIED THE PRODUCT AND BELIEVES IT GAVE HER CONJUNCTIVITIS. SHE EXPERIENCED RED, IRRITATED EYES AT THE END OF THE DAY. SHE DOESN'T REMEMBER WHEN IT WAS GIVEN TO HER ONLY THAT SHE RAN OUT OF HER OPTI-FREE SOLUTION, SO SHE STARTED USING THE EASY RUB FORMULA. CONSUMER THINKS SHE STARTED USING THE EASY RUB SOLUTION IN (B)(6) 2020. AFTER USING THE PRODUCT FOR THE FIRST TIME FOR A COUPLE OF WEEKS, SHE DEVELOPED SEVERE SYMPTOMS WITH MUCOUS DISCHARGING FROM HER EYES. HER EYES GOT PROGRESSIVELY WORSE, AND SHE REPORTS SHE DEVELOPED CONJUNCTIVITIS TWICE, FIRST IN (B)(6) WHEN IT AFFECTED BOTH EYES, AND THEN AGAIN IN (B)(6), WHEN IT CAME BACK STRONGER IN HER LEFT EYE. SHE COMMENTED THAT ONE OF HER EYES DISCHARGED PUS. SHE CONTINUED USING EASY RUB THROUGH (B)(6). THE CONSUMER WAS EXAMINED BY HER EYE CARE PROFESSIONAL AND WAS TOLD SHE HAD CONJUNCTIVITIS. SHE WAS PRESCRIBED ANTIBIOTIC DROPS, AND THEN WHEN IT RE-OCCURRED A STRONGER ANTIBIOTIC WAS PRESCRIBED. THE CONSUMER REPORTS USING GENTAMICIN TWICE A DAY FOR 5-DAYS, AND TOBRAMYCIN 1-DROP A DAY UNTIL GONE. SHE
Patient problems: Conjunctivitis; Irritation; Red Eye(s)
MAUDE report 10268515 ↗InjuryJan 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT AFTER USING COMPLETE MULTIPURPOSE SOLUTION, SHE TEMPORARILY LOST SIGHT IN BOTH EYES. SHE VISITED HER DOCTOR AND WAS PRESCRIBED DROPS. SHE TRIED USING COMPLETE MULTIPURPOSE SOLUTION AGAIN AND THE SYMPTOMS RETURNED. THROUGH FOLLOW-UP THE CONSUMER EXPLAINED THAT WHAT SHE MEANT BY VISION WAS LOST IS SEVERE BLURRY VISION WITH PAIN AND WAS UNABLE TO READ. HER LEFT EYE WAS AFFECTED THE MOST SO SHE WOULD USE HER RIGHT EYE. SHE SAW HER PHYSICIAN WHO PRESCRIBED PREDNISOLONE DROPS. SHE USED THE DROPS FOR 3 MONTHS WITHOUT CONTACTS. PER THE CONSUMER, THE DOCTOR¿S DIAGNOSIS WAS DRY SPOTS ON HER CORNEA. THE CONSUMER HAS NO HISTORY OF DRY EYE OR OTHER EYE ISSUES. THE CONSUMER FURTHER EXPLAINED THAT ONCE HER EYES FELT BETTER AFTER USING THE PRESCRIBED DROPS, SHE TRIED USING THE COMPLETE SOLUTION AGAIN. THIS TIME HER RIGHT EYE WAS MORE THE PROBLEM. CONSUMER HAS WORN CONTACTS FOR 7 YEARS. SHE WEARS DIFFERENT BRANDS OF MONTHLY DISPOSABLE SOFT CONTACT LENSES. SHE DOES NOT SHOWER OR SWIM IN THEM. CONSUMER EXPLAINED THAT WHEN SHE WENT BACK TO USING HER PREVIOUS SOLUTION, SHE DID NOT EXPERIENCE ANY ISSUES. SHE IS AFRAID THAT THERE IS STILL SOMETHING WRONG WITH HER EYES. THE CONSUM
Patient problems: Blurred Vision; Burning Sensation; Dry Eye(s); No Code Available; Pain; Red Eye(s)
MAUDE report 9630378 ↗InjuryOct 28, 2018Contamination; Contamination
IT WAS REPORTED THROUGH A MEDWATCH REPORT THAT A CONSUMER PURCHASED COMPLETE MULTI PURPOSE SOLUTION. THE CONSUMER BROUGHT IT HOME, BROKE THE SEAL, POURED IT INTO THE CONTACT CASE, AND WASHED OUT THEIR CONTACTS. THE LENS CASE WAS PUT ON THE BATHROOM SHELF. THE CONSUMER USED THE CONTACT SOLUTION FOR SEVERAL WEEKS AND STARTED DEVELOPING SORES IN THE RIGHT AND LEFT EYES. THEY WENT TO SEE THE EYE DOCTOR AND WAS REFERRED TO AN OPHTHALMOLOGIST. THE OPHTHALMOLOGIST CULTURED THE SOLUTION AND FOUND THAT IT GREW PSEUDOMONAS AERUGINOSA, AN INFECTION THAT IS METHICILLIN RESISTANT. THE CONSUMER HAS VERY LITTLE TO NO VISION IN THEIR LEFT EYE, AND IN THE RIGHT EYE IT'S HAZY, SHADOWY. THE CONSUMER HAS BEEN RESTRICTED BY THEIR DOCTOR FROM DRIVING AND WORKING. CONSUMER HAS BEEN TREATED TO HOPEFULLY RESTORE SOME OF THEIR VISION. THE DOCTOR STATED THEY ARE GOING TO HAVE A PERMANENT SCAR ACROSS THE PUPIL AND LIKELY WILL NOT REGAIN A LOT OF SIGHT IN THE LEFT EYE. ALTHOUGH THAT IS NOT YET CERTAIN. NO FURTHER INFORMATION WAS PROVIDED. MEDICATIONS PRESCRIBED: TOBRAMYCIN EYE DROPS, VANCOMYCIN EYE DROPS, PREDNISONE STEROID EYE DROPS.
Patient problems: Unspecified Infection; Visual Disturbances; Visual Impairment
MAUDE report 8012217 ↗InjuryOct 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FEMALE CONSUMER REPORTED SHE PURCHASED A BOTTLE OF COMPLETE MULTI PURPOSE DISINFECTING SOLUTION AND UPON USE OF THE PRODUCT, HER EYES WERE IRRITATED WITH A BURNING SENSATION. THE PATIENT STATED SHE WENT TO THE DOCTOR AND HER IMPAIRMENT WAS TRIVIAL AND SHE IS DOING WELL. THROUGH FOLLOW UP WITH THE CONSUMER, SHE USED THE PRODUCT AND IT MADE HER EYES BURN. SHE WENT TO THE DOCTOR AND HE PRESCRIBED SOMETHING (NAME OF MEDICATION NOT PROVIDED) AND THERE WAS A FOLLOW UP VISIT; SHE IS NOW DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Burning Sensation; Irritation
MAUDE report 6981477 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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