BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 7102864 · Received December 10, 2017

    Report

    Report Number
    9612169-2017-00217
    Event Type
    Malfunction
    Date Received
    December 10, 2017
    Report Date
    February 15, 2018
    Manufacturer
    ALCON LABORATORIES IRELAND LTD.
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE LENS REMAINS IMPLANTED. THE COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE SUFFICIENT LOT INFORMATION. HOWEVER, ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE. A ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR OF OPHTHALMOLOGY REPORTED THAT APPROXIMATELY EIGHT YEARS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IMPLANTED IOL NEEDS TO BE REPLACED DUE TO GLISTENING PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882331 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT 20909720

    Patients

    Seq Age Sex Outcome Treatment
    1 Other