BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADVANCED OPTICS ASPHERIC LENS

    MDR report key: 3042092 · Received April 3, 2013

    Report

    Report Number
    1119279-2013-00096
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS NOT BEEN EXPLANTED; THEREFORE, IT IS NOT AVAILABLE FOR EVAL. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE YEARS POST LENS IMPLANTATION, CENTRAL OPACIFICATION WAS OBSERVED ON THE IOL OPTIC. DURING THE THREE YEAR INTERVAL BETWEEN IMPLANTATION AND OPACIFICATION, THE PT UNDERWENT MULTIPLE SURGICAL PROCEDURES: VITRECTOMY WITH MEMBRANE PEEL WAS PERFORMED TWICE AND SCLERAL BUCKLE PROCEDURE ONCE FOR REPAIR OF RETINAL DETACHMENT. DEEP ANTERIOR LAMELLAR KERATOPLASTY (DALK) WAS PERFORMED NINE MONTHS AGO TO ADDRESS PT PRE-EXISTING CORNEAL SCARRING. THE MOST CURRENT BCVA WAS 20/200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135938 AKREOS ADVANCED OPTICS ASPHERIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH & LOMB AO60G 1827587

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other