BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADVANCE ASPHERIC LENS

    MDR report key: 1960979 · Received January 11, 2011

    Report

    Report Number
    1119279-2011-00006
    Event Type
    Injury
    Date Received
    January 11, 2011
    Report Date
    December 23, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AUTHORS, PATIENT - RELATED FACTORS SUCH AS AN ANTERIOR CHAMBER REACTION CAUSED BY HYPHEMA MAY HAVE BEEN RESPONSIBLE FOR THE IOL OPACIFICATION. (B)(4).

    Description of Event or Problem · 1

    BAUSCH & LOMB RECEIVED A PUBLISHED LITERATURE REPORTING LENS OPACIFICATION WITH IMPLANTATION OF AN AKREOS ADAPT INTRAOCULAR LENS IN THE RIGHT EYE. THE PT HAD UNDERGONE PARS PLANA VITRECTOMY FOR PROLIFERATIVE DIABETIC RETINOPATHY IN COMBINATION WITH PHACOEMULSIFICATION AND IMPLANTATION OF THE AKREOS IOL IN THE CAPSULAR BAG. SIX MONTHS POSTOPERATIVELY, THE PT WAS DIAGNOSED WITH NEOVASCULAR GLAUCOMA AND HYPHEMA (IOP 38MM HG). THE PATIENT'S BCVA HAD DECREASED TO COUNTING FINGERS. HE UNDERWENT AHMED VALVE IMPLANTATION THROUGH PARS PLANA VITRECTOMY. TEN MONTHS FOLLOWING THE IMPLANTATION OF THE IOL, LENS OPACIFICATION WAS DIAGNOSED WITH DECREASED VISUAL ACUITY. THE IOL WAS EXPLANTED 45 MONTHS AFTER LENS IMPLANTATION. ANOTHER IOL WAS IMPLANTED INTO THE SULCUS WITH NO COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADVANCE ASPHERIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB ADAPT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention