BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1905577 · Received November 19, 2010

    Report

    Report Number
    1119421-2010-01305
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    October 24, 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
    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 PULLED FROM THE OPTIC (NOT RETURNED). THE SECOND HAPTIC WAS BENT-GUSSET AND DISTAL AREA. THE OPTIC WAS CRACKED IN BOTH HAPTIC INSERTION AREAS. THE FOCAL LENGTH AND RESOLUTION WERE WITHIN SPECIFICATIONS. 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 HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, LIGHT SCATTERING WAS OBSERVED ON THE IOL. THE PT'S VISUAL ACUITY WAS DECREASED, SO THE IOL WAS EXCHANGED. FOLLOWING THE EXCHANGE PROCEDURE, THE PT'S VISUAL ACUITY WAS IMPROVED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH, LTD./HUNTINGTON MA60BM 885919

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention