BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 905597 · Received August 30, 2007

    Report

    Report Number
    1119421-2007-00358
    Event Type
    Injury
    Date Received
    August 30, 2007
    Date of Event
    January 1, 2007
    Report Date
    July 31, 2007
    Manufacturer
    ALCON LABORATORIES, INC. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 HAVE BEEN NO SIMILAR COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 08/02/2007 AND 08/16/2007 BY PHONE, FAX, AND MAIL. ADDITIONAL INFORMATION WAS RECEIVED 08/02/2007, 08/16/2007, 08/17/2007, AND 08/23/2007 BY PHONE. A FOLLOW-UP QUESTIONNAIRE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    A NURSE REPORTS THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PT REPORTED BLURRY VISION AND WAS NOT SATISFIED WITH THE RESULTS. THE LENSES WERE EXPLANTED AND REPLACED WITH ANOTHER MODEL. RIGHT EYE MDR # 1119421-2007-00358. LEFT EYE MDR # 1119421-2007-00359.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SN60D3 10708201

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention