BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTIC LENS

    MDR report key: 3060339 · Received April 11, 2013

    Report

    Report Number
    1119279-2013-00111
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS BEEN RETURNED TO B&L AND IS CURRENTLY UNDER EVALUATION. 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 DID NOT EXIT THE INSERTER PROPERLY AND BECAME STUCK IN THE WOUND. THE INCISION WAS ENLARGED TO REMOVE THE LENS, ANOTHER LENS WAS IMPLANTED SUCCESSFULLY AND NO SUTURES WERE NEEDED. THE PT'S CURRENT STATUS IS GOOD. PLEASE REFERENCE MDR # 1119279-2013-00112 FOR THE DELIVERY DEVICE USED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155363 SOFPORT ADVANCED OPTIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4219205

    Patients

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