BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT AO MICRO INCISION LENS

    MDR report key: 1841617 · Received September 16, 2010

    Report

    Report Number
    1119279-2010-00034
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    July 5, 2010
    Report Date
    June 22, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT (PHACO) SURGERY WITH IMPLANTATION OF THE MI60G INTRAOCULAR LENS INTO THE LEFT EYE. DURING PHACOEMULSIFICATION, THE SURGEON OBSERVED THAT THE ANTERIOR CHAMBER WAS SHALLOW AND THE IRIS PROLAPSED. APPROXIMATELY TWO MONTHS POSTOPERATIVELY FIBRIN WAS OBSERVED ON THE ANTERIOR OPTIC. THE PT WAS TREATED WITH ANTI-INFLAMMATORY MEDICATION AND A YAG CAPSULOTOMY WAS PERFORMED. PREOPERATIVELY, THE PT'S VISUAL ACUITY WAS 20/40. POSTOPERATIVELY, THE PT'S VISUAL ACUITY WAS 20/200. THE PT'S CURRENT VISUAL ACUITY IS 20/125. THE LENS REMAINS IMPLANTED AND THE PT CONTINUES TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADAPT AO MICRO INCISION LENS INTRAOCULAR LENS HQL BAUSCH + LOMB MI60G2450 1935693

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention