FINESSE REFLEX 806.13Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07612717071568), received between Jun 15, 2023 and Sep 12, 2023 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AUTHOR REPORTED VIA LITERATURE REPORTED THAT PATIENT EXPERIENCED SWELLING OF THE ARCUATE RETINAL NERVE FIBER LAYER AND DISSOCIATED OPTIC NERVE FIBER LAYER RELATED TO THE SURGICAL TRAUMA OF THE INNER RETINA WHICH IS CAUSED BY OPHTHALMIC FORCEPS. CURRENT PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Retinal Tear

  MAUDE report 17732481 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A INVESTIGATOR REPORTED IN A CLINICAL STUDY AFTER USING SURGICAL FORCEPS A MALE PATIENT EXPERIENCED WITH MACULAR EDEMA AFTER POST VITRECTOMY SURGERY. UNKNOWN INTERVENTION WAS REPORTED AND THE SYMPTOMS WERE RESOLVED.

  Patient problems: Macular Edema

  MAUDE report 17134143 ↗