BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHITESTAR SIGNATURE¿ SYSTEM

    MDR report key: 2962474 · Received February 14, 2013

    Report

    Report Number
    2020664-2013-00013
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 8, 2013
    Report Date
    May 6, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER ON (B)(4) 2013. THE MANUFACTURER REPORT NUMBER SHOULD HAVE BEEN (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    EQUIPMENT WAS RECEIVED FOR EVALUATION AFTER LEAVING THE CUSTOMER SITE. A SECOND EVALUATION WAS PERFORMED. EQUIPMENT PASSED ALL ELECTRICAL, SAFETY CHECKS, VISUAL AND FUNCTIONAL TESTING WITH NO FINDINGS/OBSERVATIONS. THE WAS NO TECHNICAL ISSUES WITH THE SYSTEM.

    Additional Manufacturer Narrative · 1

    ACCOUNT REPORTED THAT TWO WEEKS POST OPERATION, THE BURN HAD COMPLETELY DISAPPEARED WITH EYE DROP TREATMENT (OPHTACILOXAN). FIELD SERVICE VISITED SITE AFTER EVENT. THE SYSTEM WAS CHECKED (VISUAL, FUNCTIONAL AND ELECTRICAL TESTING PERFORMED) AND NO PROBLEMS WERE IDENTIFIED. THERE WAS NO OBSERVED PROBLEM ON NEITHER SURGICAL TECHNIQUE NOR USED SETTINGS. THE SYSTEM MEETS ABBOTT MEDICAL OPTICS SPECIFICATIONS. NOTE: ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT THERE WAS NO COMPLICATION DURING THE SURGERY OF A GRADE 2 CATARACT BUT THAT THE SYSTEM CAUSED A GRADE 1 CORNEAL BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65265 WHITESTAR SIGNATURE¿ SYSTEM SIGNATURE HQC ABBOTT MEDICAL OPTICS NGP680300

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention