BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 730985 · Received June 28, 2006

    Report

    Report Number
    1119421-2006-00226
    Event Type
    Injury
    Date Received
    June 28, 2006
    Report Date
    May 29, 2006
    Manufacturer
    ALCON LABS, INC/HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN IDENTIFIED. PRODUCT HISTORY RECORDS WERE REVIEWED FOR THE INTRAOCULAR LENS LOT NUMBER AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER.

    Description of Event or Problem · 1

    A NURSE FROM THE USER FACILITY REPORTED ONE CASE OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE ONLY PRODUCT INFO AVAILABLE WAS THE INTRAOCULAR LENS SERIAL NUMBER. NO PRODUCT, NO PROCEDURAL AND NO ENVIRONMENTAL COMPONENT WAS MORE SUSPECT THAN ANOTHER. THE FACILITY WAS IN THE PROCESS OF INVESTIGATING ALL POSSIBLE CAUSES OF TASS. RESOURCE MATERIALS ON TASS WERE PROVIDED TO THE REPORTER AT HER REQUEST. PHONE FOLLOW-UP REVEALED THE FACILITY HAS HAD NO OTHER CASES OF TASS SINCE THIS REPORT AND THE PT IS DOING WELL FOLLOWING TREATMENT. THE CAUSE OF THE TASS REMAINS UNK. ADDIITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABS, INC/HUNTINGTON SA60AT 910371

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention