BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ - 28 DELIVERY SYSTEM

    MDR report key: 4810574 · Received May 29, 2015

    Report

    Report Number
    1313525-2015-01552
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    April 14, 2015
    Report Date
    May 8, 2015
    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 LOT NUMBER OF THE DELIVERY DEVICE WAS NOT PROVIDED, AND THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. THEREFORE, A DEVICE HISTORY REVIEW (DHR) AND PRODUCT EVAL COULD NOT BE CONDUCTED. BASED ON THE INFO CURRENTLY AVAILABLE, THE MOST LIKELY CAUSE OF THE EVENT IS "PATIENT-RELATED." ACCORDING TO THE SURGEON, THE PT HAD A WEAK CAPSULE.

    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 THE LENS WAS REMOVED INTRAOPERATIVELY DUE TO CAPSULE RUPTURE. THE INCISION WAS ENLARGED AND SUTURES WERE PLACED. NO REPLACEMENT LENS WAS IMPLANTED AND THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. REFERENCE MDR# 1313525-2015-01551 FOR THE LENS USED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350825 EZ - 28 DELIVERY SYSTEM FOLDERS AND INJECTORS, IOL MSS BAUSCH + LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LI61AO SOFPORT INTRAOCULAR LENS (B+L)