BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2230717 · Received August 17, 2011

    Report

    Report Number
    1119421-2011-00996
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVAL: RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. NO MALFUNCTION CAN BE DETERMINED AT THIS TIME. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT WHILE TAKING THE INTRAOCULAR LENS (IOL) OUT OF ITS CONTAINER DURING THE SURGICAL PROCEDURE, HE NOTED THAT ONE OF THE HAPTICS HAS DETACHED. THE IOL WAS NOT IMPLANTED. IN A F/U, THE SURGEON REPORTED THAT THE SURGERY WAS POSTPONED FOR FOUR WEEKS AND HAS NOT YET TAKEN PLACE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON MA60AC 10847873

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other