BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 2894763 · Received December 20, 2012

    Report

    Report Number
    1119421-2012-01627
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE PRODUCT INVESTIGATION COULD NOT IDENTIFY A ROOT CAUSE. THERE WERE NO SIMILAR COMPLAINTS IN THE LOT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY PHONE, FAX AND MAIL ON (B)(6) 2012. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    A MATERIALS SPECIALIST REPORTED THAT ONE WEEK FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS WAS EXCHANGED DUE TO BECOMING DISLOCATED AND WAS NOT STABLE WITHIN THE EYE. THE LENS WAS REPLACED WITH AN ANTERIOR CHAMBER IOL. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON MN60AC 12004939

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention