BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 3030227 · Received March 27, 2013

    Report

    Report Number
    1119279-2013-00085
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY DEVICE WILL NOT BE RETURNED TO BAUSCH AND LOMB. 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 PATIENT'S RIGHT EYE DUE TO A BENT HAPTIC NOTED DURING INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER LENS OF THE SAME MODEL WAS IMPLANTED SUCCESSFULLY. THE PATIENT'S PROGNOSIS WAS REPORTED AS STABLE. PLEASE REFERENCE MDR# 1119279-2013-00084 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125288 EZ-28 DELIVERY SYSTEM MSS/ FOLDERS AND INJECTORS, IOL MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other (B)(4) SOFPORT ADVANCED OPTIC LENS (B AND L)