Alcon Grieshaber 712.00.11Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07612717062238), received between Jun 26, 2023 and Jul 2, 2024 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Corroded” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2024Corroded; Corroded

  A NURSE REPORTED THAT BEFORE SURGERY AN OPHTHALMIC MICROSCOPE EXHIBITED RUSTED BUTTON AND THAT COULD NOT BE USED. THERE WAS NO HARM CAUSED TO PATIENT. PROCEDURE DETAILS WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19654635 ↗
• MalfunctionJul 1, 2024Corroded; Corroded

  A NURSE REPORTED THAT BEFORE EPIRETINAL MEMBRANE SURGERY AN OPHTHALMIC HANDLE WAS RUSTED COULD NOT BE USED. SURGERY WAS COMPLETED WITH AN ALTERNATIVE HANDLE AND WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642557 ↗
• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED VIA A CLINICAL STUDY THAT AFTER A VITRECTOMY SURGERY A PATIENT EXPERIENCED RETINAL SURFACE DAMAGE AND HEMORRHAGE. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Retinal Tear

  MAUDE report 17207709 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT AFTER A CATARACT VITRECTOMY COMBINATION SURGERY WHILE USING AN OPHTHALMIC SCISSORS A MALE PATIENT EXPERIENCED RETINAL DETACHMENT AND INFLAMMATION. THE SURGERY WAS COMPLETED WITH SYMPTOMS IMPROVING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Inflammation; Retinal Detachment

  MAUDE report 17202825 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY SURGERY WHILE USING AN OPHTHALMIC FORCEPS AND HANDPIECE A 80 YEARS FEMALE PATIENT EXPERIENCED RETINAL DETACHMENT, DECREASED VISUAL ACUITY. PATIENT WAS HOSPITALIZED AND UNKNOWN INTERVENTION WAS GIVEN. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Detachment; Visual Impairment

  MAUDE report 17201756 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY/ CATARACT COMBINATION SURGERY WITH THE USE OF DISPOSABLE OPHTHALMIC PRODUCT A PATIENT EXPERIENCED RETINAL TEAR, DETACHMENT OF RETINA AND DECREASE IN VISUAL ACUITY. PATIENT WAS HOSPITALIZED AND INTERVENTION WAS GIVEN AND THE SYMPTOMS ARE STILL CONTINUING . NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY. THIS IS EIGHT OF ELEVEN REPORTS FOR THIS ISSUE AND REPRESENTS THE OPHTHALMIC FORCEPS.

  Patient problems: Retinal Detachment; Retinal Tear; Visual Impairment

  MAUDE report 17200015 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A COMBINATION OF CATARACT AND VITRECTOMY SURGERY TO IMPROVE VISION WHILE USING AN OPHTHALMIC PRODUCT A PATIENT EXPERIENCED RETINAL TEAR/BREAK AND DECREASED VISUAL ACUITY. PATIENT WAS HOSPITALIZED AND INTERVENTION WAS GIVEN AND THE SYMPTOMS WERE CONTINUING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Tear

  MAUDE report 17198382 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY/ CATARACT COMBINATION SURGERY WITH THE USE OF DISPOSABLE OPHTHALMIC PRODUCT A FEMALE PATIENT EXPERIENCED RETINAL TEAR, DETACHMENT OF RETINA. PATIENT WAS HOSPITALIZED AND UNKNOWN INTERVENTION WAS GIVEN, THE SYMPTOMS ARE CONTINUING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

  Patient problems: Retinal Detachment; Retinal Tear

  MAUDE report 17198266 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY/ CATARACT COMBINATION SURGERY BY USING DISPOSABLE OPHTHALMIC FORCEPS AND HANDPIECES A MALE PATIENT PATIENT EXPERIENCED EPIRETINAL MEMBRANE RECURRENCE, VITREOUS HEMORRHAGE AND PROLIFERATIVE VITREORETINOPATHY. PATIENT WAS HOSPITALIZED AND UNKNOWN INTERVENTION WAS GIVEN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Vitreous Hemorrhage

  MAUDE report 17197942 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY/ CATARACT COMBINATION SURGERY INCLUDING MEMBRANE PEELING AND REATTACHMENT OF RETINA TO PRESERVE CURRENT VISION WITH THE USE OF DISPOSABLE OPHTHALMIC PRODUCTS A PATIENT EXPERIENCED DETACHMENT OF RETINA AND DECREASE IN VISUAL ACUITY. PATIENT WAS HOSPITALIZED AND INTERVENTION WAS GIVEN AND THE SYMPTOMS WERE IMPROVING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY. THIS IS THIRD OF THREE REPORTS FOR THIS EVENT AND REPRESENTS THE OPHTHALMIC HANDLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Detachment

  MAUDE report 17197596 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY/ CATARACT COMBINATION SURGERY INCLUDING MEMBRANE PEELING AND REATTACHMENT OF RETINA TO IMPROVE CURRENT VISION WITH THE USE OF DISPOSABLE OPHTHALMIC PRODUCTS A PATIENT EXPERIENCED RETINAL TEAR, DETACHMENT OF RETINA AND DECREASE IN VISUAL ACUITY. PATIENT WAS HOSPITALIZED AND INTERVENTION WAS GIVEN AND THE SYMPTOMS WERE CONTINUING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY. THIS IS EIGHTH OF ELEVEN REPORTS FOR THIS EVENT AND REPRESENTS THE OPHTHALMIC HANDLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Detachment; Retinal Tear

  MAUDE report 17196872 ↗