REVITALENS 93744HZRecalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · BLINK REVITALENS MPDS 10OZ+LC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827444000973), received between Jul 29, 2019 and Jul 29, 2019 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burning Sensation1
- Corneal Scar1
- Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RECEIVED REPORT FROM A PATIENT REGARDING HIS EXPERIENCE WITH BLINK REVITALENS MULTIPURPOSE SOLUTION. THE PATIENT EXPERIENCED BURNING IN BOTH OF HIS EYES WHICH CAUSED SCARS THAT HE ATTRIBUTES TO USE OF THE SOLUTION. THE PATIENT CONSULTED HIS DOCTOR AND WAS PRESCRIBED STEROIDS. PER THE PATIENT, HIS DOCTOR STATED HE COULD NOT WEAR CONTACTS AS HE COULD GO BLIND. HIS EYES ARE STILL IRRITATED, AND THE PRODUCT IS NOT AVAILABLE FOR RETURN.
Patient problems: Burning Sensation; Corneal Scar; Irritation
MAUDE report 8839235 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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