BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1941927 · Received December 22, 2010

    Report

    Report Number
    1119421-2010-01488
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 30, 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 HAS NOT BEEN REC'D FOR EVALUATION; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING A PT WITH DECREASED VISUAL ACUITY AND A MILKY INTRAOCULAR LENS (IOL) TEN YEARS FOLLOWING IMPLANT SURGERY. THE DECREASE IN VISUAL ACUITY HAS BEEN OBSERVED THIS YEAR. THE CAUSAL RELATIONSHIP BETWEEN THE MILKY LENS AND THE DECREASED VISUAL ACUITY IS UNK BECAUSE RETINAL DISEASE IS ALSO OBSERVED. THE SURGEON SUSPECTS THAT THE MILKY LENS COULD BE ONE OF THE CAUSES OF THE DECREASED VISUAL ACUITY AND IS PLANNING TO EXCHANGE THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other