BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 800477 · Received December 21, 2006

    Report

    Report Number
    1119421-2006-00425
    Event Type
    Injury
    Date Received
    December 21, 2006
    Date of Event
    October 1, 2006
    Report Date
    November 21, 2006
    Manufacturer
    ALCON LABORATORIES, INC./HUNTINGTON
    Product Code
    HQL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IOL REMAINS IMPLANTED. A PIECE OF FOREIGN MATERIAL WAS RETURNED FOR TESTING. TEST RESULTS ARE PENDING AT THIS TIME. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THE FOLLOWING ADD'L INFO WAS RECEIVED DURING PHONE FOLLOW-UP ON 12/07/2006: THE SURGEON STATED THE PT WANTED TO BE LEFT MYOPIC, THAT IS WHY HER PRE-OP MR -3.00 + 1.00X090 REMAINED ALMOST THE SAME: POST-OP MR -3.25 + 2.25 X 090 WITH BCVA 20/60. IT WAS DETERMINED THAT THE NEWLY ADDED CYLINDER MAY STEM FROM THE SINGLE STITCH SUTURE THE SURGEON APPLIES ROUTINELY. A POTENTIAL ACUITY METER (PAM) BROUGHT HER UP TO 20/30. FUNDUS VISIBILITY IS POOR. A PHOTO WAS RECEIVED AND REVIEWED BY CLINICAL SCIENCE ON 12/07/2006. IT APPEARED TO CLINICAL SCIENCE THAT THERE IS A STRING-LIKE 'DEPOSIT' OF ABOUT 3MM LENGTH AND PERHAPS 2/10 MM WIDTH LOCATED ON THE ANTERIOR SURFACE FROM 1 O'CLOCK TOWARD 5 O'CLOCK. IT DOES NOT APPEAR TO BE IN THE CENTRAL VISUAL AXIS. THE SURGEON REMOVED THE FOREIGN BODY FROM THE ANTERIOR SURFACE OF THE LENS DURING A FOLLOW-UP VISIT. THE FOREIGN BODY WAS SENT TO US FOR EVALUATION ON DECEMBER 18, 2006. EVALUATION RESULTS ARE PENDING.

    Description of Event or Problem · 1

    A SURGEON REPORTS A FIBROUS MASS WAS OBSERVED ON THE ANTERIOR SURFACE OF THE INTRAOCULAR LENS (IOL). THE SURGEON FEELS IT AFFECTED THE PT'S VISION. THE PARTICLE WAS REMOVED DURING A FOLLOW-UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON LABORATORIES, INC./HUNTINGTON SN60AT 938934

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R