BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFPORT AO INTRAOCULAR LENS

    MDR report key: 3201677 · Received June 28, 2013

    Report

    Report Number
    1119279-2013-00210
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 30, 2013
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORD WAS REVIEWED FOR THE DEVICE AND THERE WERE NO NONCONFORMITIES OR ANOMALIES RELATED TO THIS COMPLAINT. NO OTHER SIMILAR COMPLAINTS WERE IDENTIFIED FOR THIS LOT. INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANTATION, THE LENS WAS EXPLANTED DUE TO PT REPORT OF "POOR" VISION AND PRACTITIONER REPORT OF LENS CLOUDINESS. ADD'L INFO HAS BEEN REQUESTED BUT NO NEW INFO HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295506 SOFPORT AO INTRAOCULAR LENS HQL; INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4100715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other