BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFLEX SILICONE SQUARE EDGE IOL

    MDR report key: 1939763 · Received December 16, 2010

    Report

    Report Number
    1119279-2010-00116
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE SILICONE (B)(4) INTRAOCULAR LENS USING THE EX-28 DELIVERY DEVICE SYSTEM. DURING LENS IMPLANTATION, THE SURGEON NOTICED THE HAPTIC WAS BENT. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. REFERENCE MDR #1119279-2010-000117.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFLEX SILICONE SQUARE EDGE IOL INTRAOCULAR LENS HQL BAUSCH + LOMB LI61SE 4015235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EZ-28 DELIVERY DEVICE (B+L)