BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTIC LENS

    MDR report key: 2960303 · Received February 8, 2013

    Report

    Report Number
    1119279-2013-00037
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS BEEN REQUESTED BUT HAS NOT 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 WOULD NOT BE POSITIONED PROPERLY IN THE PT'S EYE. THE INCISION WAS ENLARGED TO REMOVE THE LENS INTRAOPERATIVELY. ANOTHER LENS WAS IMPLANTED SUCCESSFULLY. PLEASE REFERENCE MDR# 1119279-2013-00038 FOR THE DELIVERY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54254 SOFPORT ADVANCED OPTIC LENS HQ/INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4224213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EZ-28 DELIVERY SYSTEM (B+L)