BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 1940436 · Received December 20, 2010

    Report

    Report Number
    1119279-2010-00131
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO BAUSCH + LOMB FOR EVALUATION. 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 PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE LI61AOR INTRAOCULAR LENS USING THE EZ-28 DELIVERY DEVICE. DURING LENS INSERTION, THE HAPTIC WAS BENT. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE THE LENS. A SECOND INTRAOCULAR LENS WAS IMPLANTED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. REFERENCE MDR #1119279-2010-000130.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ-28 DELIVERY SYSTEM IOL INSERTER/INJECTOR MSS BAUSCH & LOMB EZ-28 H019701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4) INTRAOCULAR LENS (B+L)