BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON D

    MDR report key: 1250656 · Received December 3, 2008

    Report

    Report Number
    3004750704-2008-00072
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    LZP
    Removal / Correction Number
    3004750704-11/13/08-001-
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER TESTED RETAINED SAMPLES FROM THE SUSPECT LOT FOR THE PRESENCE OF ENDOTOXINS. THE ANALYSIS INDICATED THE PRESENCE OF ENDOTOXINS ABOVE THE UPPER PRODUCT RELEASE SPECIFICATION. SAMPLES OF THE SUSPECT LOT FROM INVENTORY AND RETURNED UNITS FROM A CUSTOMER COMPLAINT SITE WERE SENT TO AN INDEPENDENT LABORATORY FOR ENDOTOXIN TESTING. THIS LABORATORY ALSO REPORTED POSITIVE ENDOTOXIN RESULTS ABOVE THE SPECIFICATION LIMIT. SAMPLES FROM ALL OTHER LOTS AVAILABLE FOR DISTRIBUTION WERE TESTED BY THE SAME INDEPENDENT LABORATORY. THE TEST RESULTS SHOWED ALL LOTS TO BE WITHIN THE PRODUCT SPECIFICATION FOR ENDOTOXINS. THE MANUFACTURER'S INVESTIGATION INTO THESE REPORTS CONTINUES.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED ONE INCIDENT OF A MILD INFLAMMATORY REACTION ONE DAY POST-OPERATIVE FOLLOWING INSTILLATION OF THE PRODUCT INTO ONE EYE DURING ROUTINE CATARACT EXTRACTION. PATIENT RECOVERED WITHOUT COMPLICATION FOLLOWING TREATMENT WITH RX MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALON D OPHTHALMIC VISCOSURGICAL DEVICE LZP ADVANCED MEDICAL OPTICS HEALON D UD30654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention