FINESSE REFLEX 811.13Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07612717071575), received between Apr 2, 2024 and Feb 12, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Break

  A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION AN OPHTHALMIC FORCEPS FOUND BROKEN. IT IS UNKNOWN WHETHER THE PROCEDURE WAS COMPLETED. DETAILS REGARDING PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THIS FILE PERTAINS FIRST OF THE TWO FORCEPS REPORTED FROM THE SAME FACILITY ON THE SAME EVENT DATE.

  Patient problems: Insufficient Information

  MAUDE report 24320538 ↗
• MalfunctionFeb 12, 2026Break

  A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION AN OPHTHALMIC FORCEPS FOUND BROKEN. IT IS UNKNOWN WHETHER THE PROCEDURE WAS COMPLETED. DETAILS REGARDING PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THIS FILE PERTAINS SECOND OF THE TWO FORCEPS REPORTED FROM THE SAME FACILITY ON THE SAME EVENT DATE.

  Patient problems: Insufficient Information

  MAUDE report 24320536 ↗
• MalfunctionNov 18, 2025Break; Break

  A CUSTOMER REPORTED THAT AN OPHTHALMIC FORCEPS WAS BROKEN DURING THE SURGERY SURGEON NOTICED THE FORCEPS BROKEN AFTER BEING PUT BACK THROUGH THE TROCAR AND FOREIGN BODY WAS REMOVED. SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578138 ↗
• MalfunctionMay 2, 2025Break; Break

  A CUSTOMER REPORTED THAT DURING A SURGERY THE TIP OF AN OPHTHALMIC FORCEPS BROKE OFF. PROCEDURE DETAILS WERE NOT REPORTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950627 ↗
• MalfunctionMar 28, 2025Break; Break

  A CUSTOMER REPORTED OPHTHALMIC FORCEPS BROKEN DURING SURGERY WHILE BEING USED ANTERIORLY; THE BROKEN PIECE OF FORCEPS WAS FOUND IN THE EYE, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH THE OTHER FORCEPS. AND THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21716466 ↗
• MalfunctionJan 17, 2025Break; Break

  A CUSTOMER REPORTED THAT AN OPHTHALMIC FORCEPS TIP BROKE OFF ON THE PATIENT'S EYE DURING VITRECTOMY SURGERY . THE TIP WAS REMOVED FROM THE EYE AND THE PROCEDURE WAS COMPLETED ON SAME DAY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176785 ↗
• MalfunctionJul 10, 2024Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT OPHTHALMIC FORCEPS WERE POORLY ENGAGED DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT. THEE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 19709225 ↗
• MalfunctionMay 7, 2024Difficult to Open or Close; Difficult to Open or Close

  A CUSTOMER REPORTED THAT DURING VITRECTOMY AND CATARACT COMBINATION SURGERY, AN OPHTHALMIC FORCEPS DID NOT OPEN WELL. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE'S NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260861 ↗
• MalfunctionApr 2, 2024Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC FORCEPS TIP UNABLE TO OPEN AND CLOSE. THE PROCEDURE WAS COMPLETED USING NEW DEVICE. THERE'S NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021251 ↗