BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 3252114 · Received July 24, 2013

    Report

    Report Number
    1119279-2013-00227
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 25, 2013
    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

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENT REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SURGEON ELECTED TO USE DUOVISC FOR THE PROCEDURE THIS VISCOELASTIC HAS NOT BEEN VALIDATED FOR THE SOFTPORT IOL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS REMOVED INTRAOPERATIVELY DUE TO BROKEN POSTERIOR CAPSULE. THE FACILITY DID NOT INDICATE WHETHER THE CAPSULE DAMAGE OCCURRED PRIOR TO INSERTION. A VITRECTOMY WAS PERFORMED. THIS REPORT TO THE PATIENT'S LEFT EYE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. PLEASE REFERENCE MDR # 1119279-2013-00226 FOR THE INTRAOCULAR LENS USED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344743 EZ-28 DELIVERY SYSTEM MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LI61AOR SOFTPORT ADVANCED OPTIC LENS