BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1082589 · Received July 25, 2008

    Report

    Report Number
    1119421-2008-00551
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 25, 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
    JA
    Reporter Occupation
    OTHER

    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 ADHERED TO THE ANTERIOR OPTIC SURFACE. THE CARTRIDGE WAS NOT RETURNED FOR EVAL. 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 INCLUDES THE PRODUCT MET RELEASE CRITERIA. THERE HAS BEEN ONE OTHER SIMILAR COMPLAINT REPORTED IN THE LOT NUMBER, WHICH IS FROM THIS SAME PT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A SURGEON REPORTS THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, HE FELT RESISTANCE AS HE ADVANCED THE PLUNGER TOWARDS THE CARTRIDGE. AS HE CONTINUED TO APPLY PRESSURE, THE LENS (LENS A) EJECTED RAPIDLY FROM THE CARTRIDGE INTO THE EYE. THE CAPSULE WAS NOT RUPTURED, BUT THE SURGEON COULD NOT FIND THE LENS IS IN THE PATIENT'S EYE. ONE WEEK LATER, THE SURGEON IMPLANTED ANOTHER LENS (LENS B) INTO THE CAPSULE. UPON EXAMINATION AT A LATER DATE, THE MISSING LENS WAS OBSERVED NEAR THE CILIARY BODY. ONE WEEK FOLLOWING IMPLANTATION OF LENS B, BOTH LENSES WERE REMOVED FROM THE PATIENT'S EYE. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THESE EVENTS. THIS REPORT IS FOR LENS A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD/HUNTINGTON SN60WF 10813339

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention