BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS POSTERIOR CHAMBER IOL

    MDR report key: 2000827 · Received February 17, 2011

    Report

    Report Number
    1119279-2011-00032
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 20, 2011
    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 WAS RETURNED FOR EVAL. VISUAL EVAL OF THE RETURNED LENS IDENTIFIED ONE HAPTIC WAS TORN OFF AND STUCK TO THE OPTIC. THE OPTIC WAS TORN NEARLY TO THE CENTER. THERE WAS NO OBVIOUS SCRATCH IDENTIFIED ON THE LENS. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE LENS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. IN THE PHYSICIAN'S OPINION, THE LIKELY CAUSE OF THE EVENT IS DUE TO SURGICAL TECHNIQUE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE AKREOS (B)(4) INTRAOCULAR LENS. AFTER INSERTION OF THE LENS, THE PHYSICIAN ATTEMPTED TO REMOVE ALL OF THE VISCOELASTIC. DURING THIS PROCEDURE RUPTURING OF THE POSTERIOR CAPSULE OCCURRED. THE INCISION WAS ENLARGED, AND THE LENS REMOVED. THE BACK-UP LENS WAS THEN IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS POSTERIOR CHAMBER IOL INTRAOCULAR LENS HQL BAUSCH & LOMB AO60G 1931001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention