BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF SINGLEPIECE IOL

    MDR report key: 6143776 · Received December 3, 2016

    Report

    Report Number
    9612169-2016-00156
    Event Type
    Malfunction
    Date Received
    December 3, 2016
    Date of Event
    January 17, 2016
    Report Date
    March 2, 2017
    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
    DA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE LENS REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE IOL MET RELEASE CRITERIA. ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ZIP CODE IS NOT INDICATED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE FILE REFERENCES USE OF A VISCOELASTIC WHICH IS NOT QUALIFIED FOR USE WITH THE CARTRIDGE AND ASSOCIATED LENS MODEL. THE ROOT CAUSE FOR THE REPORTED COMPLAINT COULD NOT BE DETERMINED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. BASED ON THE RESULTS FROM THE PRODUCT AND BATCH HISTORY RECORD, THE PRODUCT MET RELEASE CRITERIA. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED GLISTENINGS (SMALL BLURRY SPOTS) IN BOTH SIDES OF A LENS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794231 ACRYSOF SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60AT 21117915

    Patients

    Seq Age Sex Outcome Treatment
    1 Other