Alcon 8065922201Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380659222016), received between Jun 21, 2021 and Sep 25, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Dull, Blunt

  A physician reported that the sharpness of an ophthalmic knife was poor during surgery. The procedure was completed using another knife, with no impact to the patient. Additional information has been requested but is not available at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894962 ↗
• MalfunctionMar 26, 2026Dull, Blunt

  A PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC KNIFE DID NOT CUT PROPERLY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697049 ↗
• MalfunctionFeb 2, 2026Dull, Blunt

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE WAS UNABLE TO CUT PRIOR TO THE SURGERY. PROCEDURE TYPE AND SURGERY COMPLETION DETAILS ARE UNKNOWN. DETAILS REGARDING THE PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 24233158 ↗
• MalfunctionAug 28, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT THE KNIFE WAS DULL DURING SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912154 ↗
• MalfunctionAug 19, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE WAS DULL DURING CATARACT SURGERY. THE SURGERY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841218 ↗
• MalfunctionAug 8, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC KNIFE WAS FOUND TO BE DULL. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748699 ↗
• MalfunctionJan 29, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE COULD NOT CUT DURING CATARACT SURGERY. SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21264525 ↗
• MalfunctionSep 21, 2023Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC OPERATING KNIFE WAS NOT SHARP ENOUGH. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788402 ↗
• MalfunctionMar 17, 2023Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE WAS NOT SHARP DURING SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16563112 ↗
• MalfunctionMar 9, 2022Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT THE TIP OF AN OPHTHALMIC KNIFE NOTICED WITH A DARK GRAY (BLACK) RUBBING OF THE METAL (OR DIRT OR A SCRATCH). PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13709628 ↗
• MalfunctionMar 9, 2022Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT DURING A SURGERY THE TIP OF AN OPHTHALMIC KNIFE NOTICED WITH A DARK GRAY (BLACK) RUBBING OF THE METAL (OR DIRT OR A SCRATCH). SURGERY WAS COMPLETED USING THE SAME PRODUCT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13705923 ↗
• MalfunctionJun 21, 2021Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT DURING A SURGERY AN OPHTHALMIC KNIFE WAS BLUNT. SURGERY WAS COMPLETED AFTER REPLACING THE KNIFE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12037068 ↗