Alcon 8065441620Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380654416205), received between Aug 24, 2023 and May 8, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2024Particulates; Particulates

  A PHYSICIAN REPORTED THAT METAL PARTICLES WERE APPEARED AT THE WOUND DURING CATARACT SURGERY WHILE USING OPHTHALMIC CANNULA. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE METAL PARTICLES WERE OBSERVED AT THE MAIN WOUND WAS RETAINED. THERE WAS SWELLING IN THE WOUNDS. THE PARTICLES WERE NOT ABLE TO SEE IN POST OPERATION DUE TO EDEMA. THE PATIENT WAS ADVISED FOR A DAY MAGNETIC RESONANCE DUE TO THE MATERIAL SEEMS METALLIC. THERE WAS NO INTERVENTION AND HOSPITALIZATION FOLLOWING THE EVENT. OPHTHALMIC KNIVES WERE ALSO USED DURING PROCEDURE.

  Patient problems: Corneal Edema

  MAUDE report 19270218 ↗
• MalfunctionNov 8, 2023No Flow; No Flow

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING CANNULA WAS USED DURING THE SURGERY AND FOUND THAT PROBLEM WITH FLOW. THE SURGERY WAS COMPLETED WITH ALTERNATIVE CANNULA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093550 ↗
• InjuryAug 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT POST IMPLANTATION OF THE INTRAOCULAR LENS IN THE PATIENT'S EYE, SURGEON INSERTED NEEDLE TO THE INCISION AND NOTED THAT THE FLUID CAME OUT OF THE EYE. AFTER VIEWING UNDER THE MICROSCOPE IT WAS FOUND THAT THE NEEDLE WAS STUCK IN INCISION AND WAS LATER REMOVED IT FROM THE SAME SURGERY, THE PATIENT HAD TO PERFORM AN ADDITIONAL SURGERY OF VITRECTOMY TO REMOVE THE INTRAOCULAR LENS AS A TREATMENT, ALSO PATIENT EXPERIENCED DAMAGED CAPSULES, ZONULES, BAG COMPLEX DISLOCATE.

  Patient problems: Capsular Bag Tear

  MAUDE report 17609172 ↗