BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTIC LENS

    MDR report key: 3060343 · Received April 11, 2013

    Report

    Report Number
    1119279-2013-00106
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 5, 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 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 LENS WAS REMOVED INTRAOPERATIVELY DUE TO BENT HAPTIC. INCISION WAS ENLARGED TO REMOVE LENS AND ANOTHER LENS WAS IMPLANTED SUCCESSFULLY. NO SUTURES WERE NEEDED. THIS REPORT PERTAINS TO THE PT'S LEFT EYE. THE PT'S MOST CURRENT STATUS UCVA IS 20/25. PLEASE REFERENCE MDR# 1119279-2013-00107 FOR THE DELIVERY DEVICE USED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156700 SOFPORT ADVANCED OPTIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4213925

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other EZ-28 DELIVERY SYSTEM (B&L)