UNITY Vision System, Accessory, Active Sentry Handpiece

Description of Event or Problem

A physician reported that the patient experienced corneal edema of mild to moderate severity following cataract surgery with intraocular implantation. The patient also experienced mild corneal opacity. The corneal edema persisted for approximately 5 days and showed progressive improvement with the prescribed corticosteroid therapy. There was an initial postoperative reduction in best corrected visual acuity (BCVA) of more than 2 lines. No surgical intervention was required. Current patient outcome is recovered.This report pertains to two of the three handpieces used for the first of five patients treated at the same facility.

Additional Manufacturer Narrative

Investigation including root cause analysis is in progress. A supplemental MDR will be filed as necessary in accordance with 21 CFR 803.56 when additional reportable information becomes available. The manufacturer internal reference number is:(b)(4).H.10 reflects all related Report Numbers associated with this product event that have been submitted at this time.