BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSERT DELIVERY SYSTEM

    MDR report key: 2143071 · Received June 23, 2011

    Report

    Report Number
    1119421-2011-00785
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 24, 2011
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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. SAMPLE IS PENDING RECEIPT. ROOT CAUSE: ROOT CAUSE HAS NOT BEEN IDENTIFIED. IT WILL BE REASSESSED UPON SAMPLE RECEIPT. 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 PHARMACIST REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PLUNGER SUDDENLY PUSHED THE LENS FORWARD, BREAKING THE CAPSULAR BAG. THE IOL FELL INTO THE VITREOUS BODY. THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL, WHERE ANOTHER SURGERY WAS NECESSARY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSERT DELIVERY SYSTEM LENS GUIDE HQL ALCON RESEARCH, LTD. / HUNTINGTON NA 11039564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention