BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACRYSOF IQ NATURAL SINGLEPIECE IOL

    MDR report key: 4995221 · Received August 12, 2015

    Report

    Report Number
    9612169-2015-00569
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Report Date
    August 11, 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE LENS MET RELEASE CRITERIA. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT A PATIENT EXPERIENCED GLISTENINGS AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH NO RESPONSE TO DATE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE RIGHT EYE (OD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530460 ACRYSOF IQ NATURAL SINGLEPIECE IOL INTRAOCULAR LENS HQL ALCON LABORATORIES IRELAND LTD. SN60WF 21089454

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other