COMPLETE 93508TRHZRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · COMPLETE MPS 2X480ML+LC · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827444000652), received between Jan 23, 2019 and Jan 24, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Emits Odor” (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 Problem1
- Device Emits Odor1
Patient problems
- Red Eye(s)2
- Conjunctivitis1
- Irritation1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CONSUMER REPORTED THAT SHE EXPERIENCED REDNESS AND IRRITATION IN HER EYES AFTER USING COMPLETE MULTI PURPOSE SOLUTION. REPORTEDLY, THIS WAS HER FIRST TIME USING THE PRODUCT. ADDITIONALLY, THIS WAS THE INITIAL USE OF THE REPORTED BOTTLE OF SOLUTION. SHE WENT TO HER OPTOMETRIST AND WAS PRESCRIBED ANTIBIOTICS TO RESOLVE THE REDNESS AND IRRITATION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Irritation; Red Eye(s)
MAUDE report 8276627 ↗InjuryJan 23, 2019Device Emits Odor; Device Emits Odor
THE CONSUMER REPORTED THAT SHE SMELLED A SULPHUR ODOR AFTER SOAKING HER CONTACT LENS OVERNIGHT USING COMPLETE MULTI PURPOSE SOLUTION. AFTER SOAKING THE LENS, SHE INSERTED THE LENS AND HER RIGHT EYE BECOME RED AND PAINFUL. PATIENT MENTIONED THAT SHE WENT TO HER DOCTOR AND MAY HAVE CONJUNCTIVITIS. SHE WILL BE RETURNING TO HER DOCTOR FOR A FOLLOW UP VISIT. IN FOLLOW-UP COMMUNICATION, IT WAS LEARNED THAT THE CONSUMER RECEIVED PRESCRIPTION EYE DROPS (DOSAGE TWICE A DAY) FROM HER GENERAL PRACTITIONER TO ADDRESS HER EYE ISSUE. HER EYE IS CURRENTLY NOT AS RED, SOME DAYS SHE STILL FEELS PAIN. PATIENT ALSO CONFIRMED THE FIRST DAY OF USE WAS (B)(6) 2018, AND THAT SHE NOTICED THE ODOR UPON OPENING THE BOTTLE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Conjunctivitis; Pain; Red Eye(s)
MAUDE report 8272849 ↗
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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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