BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1030845 · Received April 17, 2008

    Report

    Report Number
    1119421-2008-00251
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    January 1, 2008
    Report Date
    March 18, 2008
    Manufacturer
    ALCON RESEARCH, LTD/ HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INTRAOCULAR LENS WAS EXAMINED AND VERIFIED TO HAVE SIGNS OF HANDLING. ONE HAPTIC WAS BROKEN-GUSSET AREA (NOT RETURNED). THE OPTIC HAD BEEN CUT INTO TWO PIECES BY AN INSTRUMENT WITH A SERRATED BLADE. LENS BENCH TESTING COULD NOT BE CONDUCTED DUE TO THE OPTIC DAMAGED.WHILE WE WERE UNABLE TO DETERMINE THE ORIGIN OF THE DAMAGE, OUR OBSERVATIONS REASONABLY SUGGEST THE DAMAGE IS NOT MFG RELATED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINT RECEIVED FOR THIS LOT NUMBER. ADDITIONAL INFO WAS REQUESTED 4/10/08 BY FAX AND MAIL. A COMPLETED QUESTIONNAIRE HAS NOT BEEN RECEIVED. THIS REPORT WAS MAILED TO FDA ON: 04/17/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTS HAVING A PT WHOSE OUTCOME WAS NOT AS EXPECTED FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE LENS WAS EXCHANGED. ADDITIONAL INFO, INCLUDING PT STATUS, HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD/ HUNTINGTON SN6AD3 10744214

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention