BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 846879 · Received May 9, 2007

    Report

    Report Number
    1119421-2007-00175
    Event Type
    Injury
    Date Received
    May 9, 2007
    Date of Event
    March 16, 2007
    Report Date
    April 9, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    F10 PT CODE 1932 AND 2571 ARE NOT LABELED. DEVICE CODE 1526 IS NOT LABELED. H.3.,6: THE PRODUCT WAS NOT RETURED FOR ANALYSIS. STERILIZATION RECORDS WERE REVIEWED AND THE STERILIZATION CYCLE RAN WITHIN ALL REQUIRED PARAMETERS WITH NO ANOMALIES. PRODUCT HISTORY RECORD AND BATCH 060854 RECORDS WERE REVIEWED LENS MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT NUMBER THE MFR'S INTERNAL REFERENCE NUMBER IS ID071307 THIS REPORT WAS MAILED TO THE FDA ON: 05/09/2007. ADDITIONAL INFO WAS REQUESTED 04/09/2007, 04/10/2007, 04/16/2007, 04/20/2007, AND 04/26/2007 BY PHONE, MAIL AND FAX. ADDITIONAL INFO WAS PROVIDED 04/16/2007 AND 04/18/2007 BY MAIL.

    Description of Event or Problem · 1

    A SURGEON REPORTED FOUR PATIENTS EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERIES. SURGERIES. SURGERIES OCCURRED OVER A THREE WEEK PERIOD AND INVOLVED TWO SURGEONS. THIS REPORT IS BEING SUBMITTED AS MFR. NUMBER 1119421-2007-00175. THE OTHER MFR. REPORT NUMBERS ARE MDR #S: 1119421-2007-00172 1119421-2007-00173 1119421-2007-00174. NO PRODUCT, PROCEDURAL OR ENVIRONMENTAL FACTOR WAS IDENTIFIED AS A CAUSE. A POSSIBLE SITE VISIT IS BEING DISCUSSED WITH THE SURGEON TO ASSIST THE FACILITY IN IDENTIFYING POSSIBLE CONTRIBUTING FACTORS IN THESE CASES OF TASS. ADDITIONAL INFO, INCLUDING PT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC. / HUNTINGTON SN60WF 964832

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention