BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 981577 · Received January 17, 2008

    Report

    Report Number
    1119421-2008-00018
    Event Type
    Injury
    Date Received
    January 17, 2008
    Date of Event
    January 1, 2007
    Report Date
    December 18, 2007
    Manufacturer
    ALCON RESEARCH, LTD/HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED 12/19/2007, 12/20/2007 AND 1/8/2008 BY PHONE, MAIL AND FAX. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    AN USER FACILITY REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS WOULD NOT CENTER IN THE SULCUS AND WAS EXPLANTED. ADDITIONAL INFORMATION, INCLUDING PATIENT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON MN60D3 972800

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention