Alcon Grieshaber RENAISSANCE 713.00.38Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07612717068285), received between Aug 9, 2022 and Jun 26, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 17201754 ↗
• 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 ELEVEN OF ELEVEN REPORTS FOR THIS ISSUE AND REPRESENTS THE OPHTHALMIC FORCEPS.

  Patient problems: Retinal Detachment; Retinal Tear; Visual Impairment

  MAUDE report 17200158 ↗
• 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 17198379 ↗
• 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 17197946 ↗
• 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 ELEVENTH 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 17196875 ↗
• MalfunctionAug 9, 2022Break; Break

  A GOVERNMENT AGENCY REPORTED THAT AN OPHTHALMIC FORCEPS BROKEN DURING A SURGERY. THIS RESULTED IN A PROLONGED OPERATION TIME AND POSSIBILITY OF FOREIGN BODY RESIDUES. THE SURGERY WAS COMPLETED SUCCESSFULLY BY REPLACING THE FORCEPS WITH ANOTHER ONE. THERE WAS NO REPORT OF ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15192640 ↗