BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 820304 · Received February 9, 2007

    Report

    Report Number
    1119421-2007-00044
    Event Type
    Injury
    Date Received
    February 9, 2007
    Date of Event
    January 1, 2007
    Report Date
    January 12, 2007
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. STERILIZATION RECORDS WERE REVIEWED AND THE STERILIZATION CYCLE RAN WITHIN ALL REQUIRED PARAMETERS WITH NO ANOMALIES. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THIS LOT NUMBER. ADDITIONAL INFO WAS REQUESTED BY FAX AND BY MAIL ON 01/17/2007. PHONE FOLLOW-UP WAS CONDUCTED ON 01/25/2007, 01/26/2007, 01/30/2007 AND 02/06/2007 WITH ADDITIONAL DATA PROVIDED. TO DATE, A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    A SURGEON REPORTED FOUR OF NINE PATIENTS DEVELOPED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT (IOL). IN THIS CASE, THE PATIENT PRESENTED WITH FIBRIN OVER THE ANTERIOR SURGACE OF THE IOL AT ONE DAY POSTOP. TWELVE DAYS FOLLOWING SURGERY, THE PATIENT PRESENTED WITH MILD CORNEAL STRIAE. INFLAMMATION HAD DISSIPATED AND HER UNCORRECTED VISUAL ACUITY WAS REPORTED AS 20/40. FOLLOW-UP WITH THE O.R. MANAGER REVEALED NO CHANGES HAVE BEEN MADE IN THE STAFF OR IN THE O.R. PROCEDURES. SHE DID MENTION THEIR FACILITY REUSES SINGLE-USE PHACO TIPS. THE CAUSE FOR THESE FOUR CASES OF TASS IS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 1119421-2007-00044--PATIENT #1; 1119421-2007-00045--PATIENT#2; 1119421-2007-00046--PATIENT #3; 1119421-2007-00047--PATIENT #4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60D3 983306

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention