BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTIC LENS

    MDR report key: 3042073 · Received April 3, 2013

    Report

    Report Number
    1119279-2013-00097
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 A LI61 LENS WAS IMPLANTED BY RETINA SPECIALIST AND ANTERIOR CHAMBER LENS WAS IMPLANTED AS A REPLACEMENT. THE REASON FOR EXPLANT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136663 SOFPORT ADVANCED OPTIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4225605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other