BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACRYSOF

    MDR report key: 1833788 · Received September 9, 2010

    Report

    Report Number
    1119421-2010-00988
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 31, 2007
    Report Date
    August 10, 2010
    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 NOT RETURNED FOR ANALYSIS; DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "DIFFICULTY SEEING" (VISION, IMPAIRED). PRODUCT PROBLEM(S): "LIGHT SCATTERING" (NO CODE AVAILABLE [IOL (INTRAOCULAR LENS) IMPLANT]). A SURGEON REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY THE PATIENT IS HAVING DIFFICULTY SEEING. THE IOLS WERE IMPLANTED IN 1996. THE SURGEON REPORTED THAT POSTERIOR CAPSULE OPACIFICATION WAS NOTED ONE MONTH POSTOPERATIVELY AND YAG LASER TREATMENTS WERE PERFORMED. FOLLOWING THE LASER TREATMENTS, THE VISUAL ACUITY IMPROVED TO 0.9 (APPROXIMATELY 20/25). THE SURGEON REPORTED THAT NOW CONSIDERABLE WHITENING OF THE IOL WAS OBSERVED AND THE PATIENT REPORTED DIFFICULTY SEEING. PRESENT VISUAL ACUITY WAS NOTED TO BE 0.1 (20/200). THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE FELLOW EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention