BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF

    MDR report key: 2491586 · Received March 9, 2012

    Report

    Report Number
    9612169-2012-00012
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    December 2, 2011
    Report Date
    February 9, 2012
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE ARE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS, (IOL) IMPLANT SURGERY A HAPTIC WAS BROKEN, CAUSING THE IOL TO BECOME DE-CENTERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21041139

    Patients

    Seq Age Sex Outcome Treatment
    1 NI