BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1813634 · Received August 13, 2010

    Report

    Report Number
    1119421-2010-00898
    Event Type
    Other
    Date Received
    August 13, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 14, 2010
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND WAS VERIFIED TO HAVE SIGNS OF HANDLING. BOTH HAPTICS WERE BROKEN-GUSSET AREA WITH A PORTION OF THE BOTH HAPTICS STILL IN THE HAPTIC INSERTION AREAS (ONE RETURNED). THE OPTIC WAS TORN/SPLIT IN BOTH HAPTIC INSERTION AREAS, CRACKED FROM THE EDGE ACROSS THE OPTIC AND TORN/SPLIT/CRACKED INTO PIECES ON TWO POSTS OF THE LENS CASE. 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. ADDITIONAL INFORMATION WAS REQUESTED ON 07/15/2010 AND 07/16/2010 BY PHONE, FAX AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 07/21/2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "SWOLLEN CORNEA" (SWELLING); "COUNT FINGERS (CF) AT THREE TO FOUR FEET" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "HAPTIC BROKE OFF" (DETACHMENT OF DEVICE COMPONENT [HAPTIC]). A SURGERY CENTER MANAGER REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, AS THE SURGEON WAS INSERTING THE LENS, THE LEADING HAPTIC BROKE OFF AND FELL INTO THE VITREOUS. THE SURGEON REMOVED AND REPLACED THE LENS DURING THE SAME PROCEDURE. THE DETACHED HAPTIC WAS LEFT IN THE VITREOUS. IN A FOLLOW-UP, THE SURGEON REPORTED THAT THE PATIENT HAS A HISTORY OF PSEUDOEXFOLIATION AND DISLOCATED HER OWN LENS WHICH THE SURGEON REMOVED TWO MONTHS AGO AND LEFT THE PATIENT APHAKIC. HE STATED THAT THIS REPORTED SURGERY WAS PLANNED WITH AN IRIS SUTURE IOL DUE TO THE PATIENT BEING APHAKIC. EIGHT DAYS AFTER SURGERY, THE SURGEON REPORTED THAT THE PATIENT'S CORNEA WAS SWOLLEN, VISUAL ACUITY WAS COUNT FINGERS (CF) AT THREE TO FOUR FEET, AND INTRAOCULAR PRESSURE WAS 20 MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60AC 10868615

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other HEALON| VISCOAT