Alcon 8065751448Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380657514489), received between Jun 28, 2023 and Oct 9, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2023Component Missing; Component Missing

  A PHYSICIAN REPORTED THAT DURING RETINAL DETACHMENT/VITRECTOMY PROCEDURE THE TROCAR DID NOT HAVE A METAL SLEEVE. THE METAL SLEEVE WAS RETAINED IN THE EYE AND IN STERILE FIELD. THERE WAS NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED. THERE WAS AN EXTENDED OR TIME DUE TO SEARCHING FOR THE METAL SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894215 ↗
• MalfunctionJun 28, 2023Component Missing; Component Missing

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC ENTRY SYSTEM CANNULA WAS MISSING DURING SURGERY. SURGERY WAS COMPLETED WITH AN ALTERNATE WITH NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222264 ↗