Alcon 8065751449Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380657514496), received between Apr 19, 2022 and Jul 14, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Dull, Blunt

  Patient problems: Insufficient Information

  MAUDE report 25812583 ↗
• MalfunctionJul 8, 2026Dull, Blunt

  Patient problems: Insufficient Information

  MAUDE report 25747345 ↗
• MalfunctionJun 18, 2026Dull, Blunt

  A NURSE REPORTED THAT A FOUR OPHTHALMIC ENTRY SYSTEM BLADES FROM THE SAME LOT NUMBER WAS FOUND TO BE NOT SHARP BEFORE THE SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NEW PRODUCT WITHOUT NO PATIENT HEALTH IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545645 ↗
• MalfunctionJan 16, 2026Dull, Blunt

  A NURSE REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC TROCAR CANNULA TIP WAS TOO BLUNT TO PERFORM EFFECTIVE CUTTING. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER CHANGED A NEW ONE. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24090940 ↗
• MalfunctionJan 8, 2026Dull, Blunt

  A CUSTOMER REPORTED THAT AN OPHTHALMIC TROCAR TIP WAS TOO BLUNT TO PERFORM EFFECTIVE CUTTING DURING VITRECTOMY SURGERY. NO PATIENT HARM WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24001385 ↗
• MalfunctionNov 6, 2025Dull, Blunt; Dull, Blunt

  THE GOVERNMENT AGENCY REPORTED THAT DURING VITRECTOMY SURGERY OPHTHALMIC ENTRY SYSTEM BLADE WAS BROKEN AND SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE NEW PRODUCT WITHOUT ANY PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493812 ↗
• MalfunctionDec 26, 2023Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT AN OPHTHALMIC TROCAR KNIFE FAILED TO PUNCTURE SCLERA DURING THE SURGERY. SURGERY WAS COMPLETED USING ANOTHER PRODUCT AND PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18391940 ↗
• MalfunctionApr 19, 2022Fitting Problem; Fitting Problem

  A GOVERNMENT AGENCY REPORTED THAT DURING A VITRECTOMY PROCEDURE THE HEAD OF STAB KNIFE WAS TIGHTLY CONNECTED TO THE SCLERAL NAIL WHICH RESULTED IN FACING DIFFICULTY TO EXTRACT THE HEAD FROM THE NAIL. THE SURGERY WAS COMPLETED AFTER A NEW REPLACEMENT WAS USED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141556 ↗