BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 5086756 · Received September 18, 2015

    Report

    Report Number
    9612169-2015-00591
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Report Date
    September 18, 2015
    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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ROOT CAUSE HAS NOT BEEN IDENTIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A SENIOR OPHTHALMIC SISTER REPORTED THAT A PATIENT PRESENTED WITH HAZY LENSES AFTER A BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE OPHTHALMOLOGIST WHO CLARIFIED THAT THE IOL SHOWED CONCENTRATED 'GLISTENING' ON BOTH SIDES. THE DETAILS OF SURGERY WERE NOT AVAILABLE NOR THE IOL PARTICULARS, AS THE RECORDS WERE NOT AVAILABLE. THE OPHTHALMOLOGIST WOULD VISIT THE PATIENT AGAIN IN 3-4 MONTHS. THIS IS ONE OF TWO REPORTS BEING FILED FOR THIS PATIENT. THIS REPORT IS FOR THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617787 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SA60AT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other