Alcon Grieshaber 725.03Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07612717071391), received between Apr 26, 2021 and Jul 21, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (3 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 18, 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.

• MalfunctionJul 21, 2025Activation Problem; Activation Problem

  A PHYSICIAN REPORTED THAT DURING A COMBINED CATARACT AND VITRECTOMY SURGERY, THE OPHTHALMIC HANDPIECE COULD NOT BE OPENED OR CLOSED DURING INSERTION. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22552787 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL SURVEY REVEALED THAT AFTER CATARACT VITRECTOMY SURGERY A MALE PATIENT EXPERIENCED ELEVATED INTRAOCULAR PRESSURE WHILE USING OPHTHALMIC FORCEPS AND HANDPIECE IT WAS TREATED WITH UNKNOWN MEDICATION. CURRENT PATIENT SYMPTOMS WAS RESOLVED. AGE OF THE PATIENT WAS REPORTED FROM 50 TO 79 YEARS, EXACT AGE AT THE TIME OF THE EVENT WAS UNKNOWN .

  Patient problems: Intraocular Pressure Increased

  MAUDE report 17198723 ↗
• MalfunctionMar 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT BEFORE A VITRECTOMY AN OPHTHALMIC HANDPIECE HAD RECOGNITION FAILURE BEFORE INSERTION. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483711 ↗
• MalfunctionFeb 24, 2023Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED THAT OPHTHALMIC HANDPIECE TIP LOCKING PART WAS NOT PROPERLY ENGAGED AND COULD NOT BE LOCKED WHEN OPENED. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE IS UNKNOWN. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16437348 ↗
• MalfunctionSep 12, 2022Difficult to Open or Close; Difficult to Open or Close

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC FORCEPS TIP DID NOT OPEN AND CLOSE DURING A SURGERY. THE SURGERY WAS COMPLETED WITHOUT PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403014 ↗
• MalfunctionMay 7, 2022Loss of or Failure to Bond; Gas/Air Leak; Loss of or Failure to Bond; Gas/Air Leak

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC PNEUMATIC HANDPIECE PRESENTED PROBLEM WITH AIR LEAKAGE AND COULD NOT GRASP SURGICAL SITE DURING A VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY BY USING AN ALTERNATE HANDPIECE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316038 ↗
• MalfunctionNov 23, 2021Connection Problem; Connection Problem

  A CUSTOMER REPORTED THAT BEFORE SURGERY THE TIP OF HANDPIECE WAS NOT AFFIXED AND THE PART PUT TOGETHER CAME OFF. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861716 ↗
• MalfunctionNov 23, 2021Connection Problem; Connection Problem

  A PHYSICIAN REPORTED THAT PRIOR TO PERFORMING A COMBINATION CATARACT AND VITRECTOMY SURGERY, THE PNEUMATIC HANDPIECE CONNECTOR WAS BAD PREVENTING THE OPHTHALMIC FORCEPS FROM SUCCESSFULLY ATTACHING TO THE HANDPIECE. AN ALTERNATE PNEUMATIC HANDPIECE WAS OBTAINED SO THAT THE SCHEDULED SURGERY COULD BE COMPLETED. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858944 ↗
• MalfunctionApr 26, 2021Connection Problem; Connection Problem

  A PHYSICIAN REPORTED THAT THE CONNECTION PART OF AN OPHTHALMIC PNEUMATIC HANDPIECE WOULD NOT ALLOW FOR A FORCEPS TIP TO SCREW IN AND CONNECT PRIOR TO PERFORMING THE SCHEDULED COMBINATION CATARACT AND VITRECTOMY SURGERY. THERE WAS NO HARM TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11727571 ↗