BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AMO INTRAOCULAR LENS

    MDR report key: 4712361 · Received April 21, 2015

    Report

    Report Number
    2648035-2015-00245
    Event Type
    Injury
    Date Received
    April 21, 2015
    Report Date
    March 27, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: MONOFOCAL/HQL IS SELECTED TO FACILITATE REPORT. ACTUAL MODEL IS UNKNOWN. BRAND, MODEL, SERIAL NUMBER,EXPIRATION DATE WERE NOT PROVIDED EXPLANT DATE: NOT APPLICABLE; STILL IMPLANTED. INITIAL REPORTER TELEPHONE: (B)(6). PMA 510(K): UNKNOWN SINCE THE MODEL IS UNKNOWN. MFG DATE: UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A SURGEON THAT HE HAD A PATIENT WHO IS ''DISABLED'' BY GLARE SINCE BEING IMPLANTED WITH AN UNKNOWN ABBOTT MEDICAL OPTICS INTRAOCULAR LENS (IOL). THE IOL HAS BEEN IMPLANTED FOR ''MAYBE TWO YEARS''. NO ADDITIONAL INFORMATION WAS PROVIDED NOR FORTHCOMING AFTER FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264537 UNKNOWN AMO INTRAOCULAR LENS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other