BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTIC LENS

    MDR report key: 3030205 · Received March 27, 2013

    Report

    Report Number
    1119279-2013-00084
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BAUSCH AND LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS REQUESTED, BUT HAS NOT BEEN RECEIVED BY BAUSCH AND LOMB. 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 RIGHT EYE DUE TO A BENT HAPTIC NOTED DURING INSERTION. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER LENS OF THE SAME MODEL WAS IMPLANTED SUCCESSFULLY. THE PATIENT'S PROGNOSIS WAS REPORTED AS STABLE. PLEASE REFERENCE MDR# 1119279-2013-00085 FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126079 SOFPORT ADVANCED OPTIC LENS HQL / INTRAOCULAR LENS HQL BAUSCH AND LOMB LI61AOR 4927413

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other EZ-28 DELIVERY SYSTEM (B AND L)