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HEALON 10290953Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · HEALON 0.85 ML US · Class 3

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 00385445084212), received between Aug 30, 2018 and Aug 30, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Contamination /Decontamination Problem1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 30, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

    IT WAS REPORTED THAT UNDEFINED BLUE STRIP PRESENTED WHILE THE DOCTOR INJECTING HEALON 0.85 INTO PATIENT'S EYE FOR CATARACT SURGERY. REPORTEDLY, A FOREIGN MATERIAL CAME OUT THE SYRINGE HALFWAY THROUGH THE INJECTION. THE PATIENT'S EYE WAS THEN RINSED AND THE FOREIGN MATERIAL WAS REMOVED FROM THE EYE AS THE PATIENT UNDERWENT A CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION WITH NO APPARENT COMPLICATIONS. NO ADDITIONAL INFORMATION PROVIDED.

    Patient problems: No Code Available

    MAUDE report 7832599 ↗

Other AID, SURGICAL, VISCOELASTIC devices

All AID, SURGICAL, VISCOELASTIC devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.