BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLUGEL

    MDR report key: 739362 · Received July 21, 2006

    Report

    Report Number
    3002037047-2006-00073
    Event Type
    Injury
    Date Received
    July 21, 2006
    Report Date
    November 17, 2005
    Manufacturer
    S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO MANUFACTURING DOCUMENTATION.

    Description of Event or Problem · 1

    THE NURSE REPORTED THE FACILITY HAS HAD PATIENTS EXPERIENCING TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING CATARACT SURGERY. THE NUMBER OF PATIENTS AND THEIR IDENTIFIERS IS NOT KNOWN. THE NURSE STATED THE CAUSE OF TASS IS NOT KNOWN AND THEY ARE NOT BLAMING ANY PRODUCT. THEY ARE INVESTIGATING ALL POSSIBLE CAUSES INCLUDING CLEANING, REPROCESSING AND STERILIZING OF THEIR REUSABLE SURGICAL INSTRUMENTS AND PRODUCTS USED IN THE O.R. THE NURSE REPORTED THEY HAD SIMILAR EVENTS A COUPLE OF YEARS AGO AND IT WAS RESOLVED. THE CAUSE OF THE PREVIOUS TASS EVENTS IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELLUGEL VISCOELASTIC SOLUTION LZP S.A. ALCON-COUVREUR N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention CILOXAN| LEGACY HANDPIECE| MYDFRIN| MYDRIACYL| VOLTRAREN| CYCLOGYL