BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1232211 · Received November 14, 2008

    Report

    Report Number
    1119421-2008-00920
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ALCON RESEARCH, LTD./ HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. ONE HAPTIC WAS BENT DUE TO THE POSITION OF THE LENS IN THE CASE. THE SECOND HAPTIC WAS BROKEN -GUSSET AREA (RETURNED ADHERED TO THE POSTERIOR OPTIC SURFACE). THE OPTIC HAD A SCRAPE MARK - REJECTABLE ON THE POSTERIOR SURFACE. WHILE WE ARE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATION REASONABLY SUGGESTS THAT IT IS NOT MANUFACTURING RELATED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 10/15/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 10/24/2008. THIS REPORT WAS MAILED TO FDA ON: 11/14/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A BROKEN HAPTIC WAS NOTED. ENLARGEMENT OF THE INCISION WAS REQUIRED TO REMOVE AND REPLACE THE IOL. IN A FOLLOW-UP THE SURGEON REPORTS THE OUTCOME OF THE EVENT AS "EXCELLENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./ HUNTINGTON SN60T5 10826384

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention VISCOELASTIC