BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTIC LENS

    MDR report key: 3030223 · Received March 27, 2013

    Report

    Report Number
    1119279-2013-00086
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BAUSCH AND LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS NOT BEEN RETURNED TO BAUSCH AND LOMB FOR 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 INTRAOCULAR LENS WAS REMOVED INTRAOPERATIVELY FROM THE PATIENT'S EYE DUE TO HAPTIC DAMAGE. THE INCISION WAS ENLARGED TO REMOVE THE LENS. ANOTHER LENS WAS IMPLANTED SUCCESSFULLY. PLEASE REFERENCE MDR# 1119279-2013-00087 FOR THE DELIVERY DEVICE USED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126088 SOFPORT ADVANCED OPTIC LENS HQL / INTRAOCULAR LENS HQL BAUSCH AND LOMB LI61AOR 4226516

    Patients

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