BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTPORT ADVANCED OPTIC LENS

    MDR report key: 3121929 · Received May 15, 2013

    Report

    Report Number
    1119279-2013-00153
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS BEEN RETURNED TO B+L AND IS CURRENTLY UNDER EVALUATION. RESULTS WILL BE SUBMITTED TO THE FDA IN A SUPPLEMENTAL REPORT. 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 A CAPSULAR TEAR WAS NOTED DURING LENS IMPLANTATION. THE SURGEON ATTEMPTED TO PLACE THE INTRAOCULAR LENS IN THE SULCUS BUT WAS UNABLE TO POSITION IT PROPERLY. THE LENS WAS REMOVED AND THE PT WAS LEFT APHAKIC. THE PT WAS SEVERELY NEARSIGHTED PRIOR TO SURGERY AND THE PHYSICIAN BELIEVES THE PT MAY FUNCTION WILL WITHOUT AN INTRAOCULAR LENS. PLEASE REFERENCE MDR# 1119279-2013-00154, FOR THE DELIVERY DEVICE USED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215304 SOFTPORT ADVANCED OPTIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH + LOMB LI61AOR 4016009

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other EZ-28 DELIVERY SYSTEM (B+L)