BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF TORIC

    MDR report key: 1052748 · Received May 23, 2008

    Report

    Report Number
    1119421-2008-00370
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    January 1, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ALCON RESEARCH, LTD./HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. ONE HAPTIC WAS BROKEN-DISTAL AREA (NOT RETURNED). THE OPTIC WAS TORN/SPLIT/CRACKED AGAINST A POST OF THE LENS CASE. THE DAMAGE APPEARS INDICATIVE OF LENS CASE RELATED DAMAGE. ALL PRODUCTS ARE 100% INSPECTED PRIOR TO PRODUCT RELEASE AND THIS DAMAGE EXCEEDS ACCEPTANCE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED 04/25/2008 AND 05/16/2008. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 05/23/2008.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED A CRACKED INTRAOCULAR LENS. IT IS KNOWN WHETHER THE LENS WAS CRACKED WHEN THE PACKAGE WAS OPENED OR IF IT HAPPENED DURING LOADING. PT IMPACT IS UNK. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON SN60T3 10747361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA