ALLEGRO OCULYZER

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY¿S ACCEPTANCE CRITERIA. THE SYSTEM WAS REPLACED WITH A LOANER AND WAS SENT FOR REPAIR AND EVALUATION. THE ERROR COULD BE REPRODUCED. THE EVALUATION IS DONE WITH THE SUPPLIER AND IS STILL IN PROGRESS. THE ROOT CAUSE COULD NOT BE IDENTIFIED CONCLUSIVELY UNTIL THE SAMPLE EVALUATION IS NOT FINISHED. THE MOST LIKELY ROOT CAUSE IS A DEFECT OF CAMERA ELECTRONICS DUE TO WEAR. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

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).

Description of Event or Problem

A CLINIC'S ENGINEER/TECHNICIAN REPORTED NON-TRUSTY MEASUREMENT RESULTS DURING DIAGNOSTIC TESTING ON SEVEN PATIENTS. THERE IS NO POSSIBILITY TO RE-MEASURE CORRECTLY. ALL THE REQUIRED STEP-BY-STEP TROUBLESHOOTING WAS DONE BUT THE PROBLEM STILL REMAINS AND UNIT IS UNSTABLE. UPON FOLLOW UP, IT WAS REPORTED THAT MEASUREMENTS WERE NOT USED FOR THE PATIENTS SURGERY. NO UNEXPECTED END RESULTS OCCURRED. NO PATIENT HARM REPORTED. SEVEN PATIENTS WERE REPORTED INVOLVED. THERE WERE NO UNEXPECTED END RESULTS REPORTED. NO PATIENT INFORMATION WAS AVAILABLE AS THE DOCTOR DID NOT USE RESULTS OF MEASUREMENTS BECAUSE THEY WERE NOT TRUSTY. ANOTHER PIECE OF EQUIPMENT WAS USED FOR DIAGNOSTICS.