BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT SQUARE EDGE LENS

    MDR report key: 2792293 · Received October 12, 2012

    Report

    Report Number
    1119279-2012-00239
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    August 21, 2012
    Report Date
    September 12, 2012
    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 AFTER THE LI61SE INTRAOCULAR LENS WAS INSERTED INTO THE PT'S EYE, THE SURGEON NOTICED THAT THE TRAILING HAPTIC WAS BENT. DURING THE REMOVAL OF THE LENS VITREOUS PROLAPSE OCCURRED AND AN ANTERIOR CHAMBER LENS WAS IMPLANTED SUCCESSFULLY. THE PT'S MOST RECENT BCDVA WAS REPORTED AS 20/40. THE PT'S PROGNOSIS IS GOOD. PLEASE REFERENCE MDR# 1119279-2012-00240 FOR THE DELIVERY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFPORT SQUARE EDGE LENS HQL/INTRAOCULAR LENS HQL BAUSCH + LOMB LI61SE 4215023

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other DELIVERY SYSTEM (B+L), EZ-28