BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1082586 · Received July 25, 2008

    Report

    Report Number
    1119421-2008-00564
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    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
    FL, 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 OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO WAS REQUESTED ON 06/30/2008 VIA FAX AND MAIL AND 07/07/2008, 07/14/2008 AND 07/21/2008 VIA PHONE. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A TECHNICIAN REPORTS THAT FOLLOWING INTRAOCULAR LENS (IOL) SURGERY, THE SURGEON OBSERVED A HAPTIC IN THE ANTERIOR CHAMBER, A TEAR IN THE POSTERIOR CAPSULAR BAG, AND VITREOUS PROLAPSE. SHE STATES THAT THE IOL WAS REMOVED AND REPLACED WITH A DIFFERENT MODEL DURING AN ADDITIONAL SURGICAL PROCEDURE. TECHNICIAN ALSO REPORTED THAT FOLLOWING EXPLANT, THE PT EXPERIENCED AN IRREGULAR NON-RESPONSIVE PUPIL WITH SOME RESIDUAL CORNEAL EDEMA. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON NI 10718308

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention