ALCON 00380650003935Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380650003935), received between Apr 23, 2026 and Apr 23, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 5, 2025Open, Classified

   Due to incomplete seals in the pouch which provide the sterile barrier.

   Z-0306-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 23, 2026Defective Device

  A NURSE REPORTED THAT WHEN PLACING THE ITEM INTO THE MACHINE, THE NURSE NOTED THE OIL WAS NOT INFUSING. WHEN TRYING TO DETACH THE ITEM, THE BLACK RUBBER STOPPER STARTED TO BREAK APART AND USED ANOTHER ITEM AND THE SAME THING HAPPENED DURING THE RETINAL DETACHMENT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS PATIENT CONTACT WITH SUSPECT PRODUCT BUT NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24964793 ↗