BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES MULTIFOCAL HYBRID CONTACT LENS

    MDR report key: 3236034 · Received July 2, 2013

    Report

    Report Number
    3005087645-2013-00003
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    April 12, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    OBO
    PMA / PMN Number
    K083291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RELATED TO THE FOLLOWING ADD'L DEVICE: MODEL NUMBER SM73F-0125+STDLG; LOT NUMBER 047549; EXPIRATION DATE 10/2017. MANUFACTURE DATE 11/2012. THE LENSES WERE NOT RETURNED TO SYNERGYEYES, INC AS THE PT DISPOSED OF THE LENSES.

    Description of Event or Problem · 1

    ON (B)(6) 2013 SYNERGEYES REC'D A COMPLAINT WHERE IN AFTER WEARING SYNERGEYES LENSES FOR APPROXIMATELY 6 MONTHS THE PT DEVELOPED AN ULCER ON EACH EYE. THE PRACTITIONER'S OFFICE STAFF MEMBER STATED THAT THE PRACTITIONER INSTRUCTED THE PT TO USE SUSTAIN ARTIFICIAL TEARS (OTC PRODUCT). THE PRACTITIONER'S FOLLOW-UP CALL TO THE PT ON (B)(6) 2013 DETERMINED THAT THE PT'S ULCERS HAD HEALED, ALTHOUGH THIS WAS NOT PHYSICALLY VERIFIED BY THE PRACTITIONER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300757 SYNERGEYES MULTIFOCAL HYBRID CONTACT LENS CONTACT LENS OBO SYNERGEYES, INC. SM73F-0175+STDSM 047609

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention