BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 3030310 · Received March 28, 2013

    Report

    Report Number
    1119279-2013-00090
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    December 12, 2012
    Report Date
    February 27, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 LI61 LENS WAS REMOVED INTRAOPERATIVELY DUE TO LACK OF CAPSULAR SUPPORT. THE LENS WAS NOT FULLY INSERTED AND THERE WAS NO ENLARGEMENT OF THE INCISION. ACCORDING TO THE SURGEON THE EVENT WAS DUE TO ZONULAR DEHISCENCE (POSSIBLY PRE-EXISTING CONDITION) AND CAPSULAR RUPTURE. THE PATIENT WAS LEFT APHAKIC AND WILL NEED IOL IMPLANTATION AT A LATER DATE. PLEASE REFERENCE MDR NUMBER 1119279-2013-00089 FOR THE INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127658 EZ-28 DELIVERY SYSTEM MSS/FOLDERS AND INJECTORS, IOL MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SOFPORT ADVANCED OPTIC LENS (B+L): LI61AOR