BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 3042093 · Received April 3, 2013

    Report

    Report Number
    1119279-2013-00095
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE HAS BEEN RETURNED TO BAUSCH+LOMB FOR EVAL. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS REMOVED INTRAOPERATIVELY FROM THE PT'S LEFT EYE DUE TO A BENT HAPTIC THAT OCCURRED DURING LOADING OF THE LENS INTO THE INJECTOR. THE INCISION WAS ENLARGED TO REMOVE THE LENS. ANOTHER LENS WAS IMPLANTED SUCCESSFULLY. PLEASE REFERENCE MDR# 1119279-2013-00094 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136258 EZ-28 DELIVERY SYSTEM MSS/FOLDERS AND INJECTORS, IOL MSS BAUSCH & LOMB, INC. EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LI61AOR SOFPORT ADVANCED OPTIC LENS (B+L)