BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1243138 · Received November 21, 2008

    Report

    Report Number
    1119421-2008-00946
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    January 23, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE DATABASE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. NO RECORDS HAVE BEEN PROVIDED THAT INDICATE THIS LENS WAS IMPLANTED IN THIS PATIENT OR THAT ANY ALCON MEDICAL DEVICES WERE USED IN SURGERY ON THIS PATIENT. ADDITIONALLY, INTERNAL RECORDS WERE REVIEWED AND THERE IS NO INDICATION THIS SURGEON USED THIS LENS DURING THIS TIME PERIOD. ADDITIONAL INFORMATION WAS REQUESTED ON 11/10/2008 BY FAX AND MAIL.

    Description of Event or Problem · 1

    AN ATTORNEY REPORTS HIS CLIENT EXPERIENCED COMPLICATIONS (UNSPECIFIED) WHICH MAY AFFECT HER SIGHT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE ATTORNEY STATED ADDITIONAL SURGICAL PROCEDURES (UNSPECIFIED) WERE PERFORMED ON CONSUMER'S EYE; SHE EXPERIENCED PAIN AND SUFFERING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SA60AT NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention