BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 3122239 · Received May 17, 2013

    Report

    Report Number
    9612169-2013-00020
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    January 1, 2007
    Report Date
    April 18, 2013
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A USER FACILITY PROVIDED THE IMPLANT DATE OF A PATIENT WITH ENDOPHTHALMITIS FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE FIVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS FILE IS FOR A PATIENT IMPLANTED WITH AN IOL ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219743 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 100555

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other