BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF TORIC

    MDR report key: 1063207 · Received June 19, 2008

    Report

    Report Number
    1119421-2008-00445
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 25, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. ONE HAPTIC WAS BENT-GUSSET AND DISTAL AREA AND WAS NICKED/CHIPPED ON THE EDGE. WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MANUFACTURING RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADD'L INFO WAS REQUESTED ON 05/22/2008 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 06/19/2008.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, IT WAS OBSERVED THAT THE LENS WAS DAMAGED. THE INCISION WAS ENLARGED TO ACCOMMODATE REMOVAL OF THE LENS. ANOTHER LENS OF THE SAME MODEL WAS IMPLANTED. IN A FOLLOW-UP, THE SURGEON REPORTS OUTCOME OF EVENT FOR PT AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF TORIC INTRAOCULAR LENS HQL ALCON RESEARCH, LTD. / HUNTINGTON SN60T4 10813042

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention ECONOPRED| BSS WITH EPINEPHRINE| NEVANAC| OCUCOAT| VIGAMOX| XYLOCAINE| BSS