UNITY CATARACT FMS PROCEDURE PACK

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.

Description of Event or Problem

A CUSTOMER REPORTED THAT THERE WAS DISPLAY OF ERROR CODE DURING CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION) SURGERY IN THE RIGHT EYE OF A MALE ELDERLY PATIENT. THE INCIDENT RESULTED IN PROLONGED DELAY IN THE START AND PROGRESSION OF THE SURGICAL PROCEDURES CAUSING ANXIETY AND DISCOMFORT IN PATIENT REQUIRING SUPPLEMENTAL SEDATION AND OXYGEN THERAPY, AS WELL AS DELAYING THEIR POSTOPERATIVE DISCHARGE. ALTHOUGH INPATIENT ADMISSION WAS NOT REQUIRED; MANAGEMENT WAS OUTPATIENT-BASED AND THE PATIENT WAS PRESCRIBED WITH TOPICAL OPHTHALMIC DROPS PER STANDARD POST-CATARACT SURGERY PROTOCOL. THERE WAS NO NEGATIVE CONSEQUENCES ON THE PATIENT AND THE PATIENT WAS RECOVERING. THIS REPORT PERTAINS TO ONE OF THE TWO CASSETTES INVOLVED IN REPORTED EVENTS.