Alcon Grieshaber REVOLUTION 705.45Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07612717068490), received between Jun 26, 2023 and Jun 26, 2023 — classified as 6 injuries.

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 Disturbances

  MAUDE report 17201450 ↗
• 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 ONE OF ELEVEN REPORTS FOR THIS ISSUE AND REPRESENTS THE OPHTHALMIC FORCEPS.

  Patient problems: Retinal Detachment; Retinal Tear; Visual Impairment

  MAUDE report 17200009 ↗
• 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, RETINAL DETACHMENT 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 Detachment; Retinal Tear

  MAUDE report 17198380 ↗
• 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 17198263 ↗
• 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 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 17197945 ↗
• 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 ONE OF ELEVEN REPORTS FOR THIS EVENT AND REPRESENTS THE OPHTHALMIC FORCEPS.

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

  MAUDE report 17196786 ↗