BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT ADVANCED OPTIC LENS

    MDR report key: 3113618 · Received May 9, 2013

    Report

    Report Number
    1119279-2013-00148
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 THE LENS WAS REMOVED INTRAOPERATIVELY DUE TO LACK OF CAPSULAR SUPPORT. THE INCISION WAS ENLARGED, A VITRECTOMY WAS PERFORMED, AN ANTERIOR CHAMBER LENS WAS IMPLANTED AND SUTURES WERE PLACED. ACCORDING TO THE SURGEON THE MOST LIKELY CAUSE OF THE EVENT WAS PT CONDITION (WEAK CAPSULE). THE PT'S CURRENT STATUS IS GOOD. PLEASE REFERENCE MDR# 1119279-2013-00149 FOR THE DELIVERY DEVICE USED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204908 SOFPORT ADVANCED OPTIC LENS HQL/INTRAOCULAR LENS HQL BAUSCH + LOMB LI61AOR 4233127

    Patients

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