BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTIC LENS

    MDR report key: 3082467 · Received April 24, 2013

    Report

    Report Number
    1119279-2013-00133
    Event Type
    Injury
    Date Received
    April 24, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED TO BAUSCH + LOMB FOR 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 INTRAOCULAR LENS WAS REMOVED INTRAOPERATIVELY FROM THE PT'S RIGHT EYE DUE TO A POSTERIOR CAPSULE TEAR. ACCORDING TO THE SURGEON, THE TEAR WAS CAUSED BY SUDDEN PT MOVEMENT. VITRECTOMY WAS PERFORMED AND SUTURE WAS USED TO CLOSE THE WOUND. NO IOL WAS IMPLANTED BECAUSE A CHOROIDAL HEMORRHAGE DEVELOPED INTRAOPERATIVELY. THE SURGEON INDICATED THE POSSIBILITY OF LENS PLACEMENT IN THE FUTURE DEPENDING ON THE RESOLUTION OF CHOROIDAL HEMORRHAGE. PLEASE REF MFR # 1119279-2013-00134 FOR THE DELIVERY DEVICE USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175921 SOFPORT ADVANCED OPTIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4232101

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other EZ-28 DELIVERY SYSTEM (B+L)