BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES HYBRID CONTACT LENS

    MDR report key: 3934998 · Received June 23, 2014

    Report

    Report Number
    3005087645-2014-00016
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SYNERGEYES
    Product Code
    HQD
    PMA / PMN Number
    K052675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE FACT THAT THE LENS AND VIAL IN QUESTION ARE FROM AN ULTRA HEALTH DIAGNOSTIC KIT, SYNERGEYES DETERMINED THAT THE LENS COLD HAVE BEEN FROM ONE OF THREE POSSIBLE LOTS: 056400, 057419, 07452 AND THE VIAL COULD HAVE BEEN FROM TWO POSSIBLE VIAL LOTS: RC03538 OR RC03647. LOTS, EXPIRATION DATES, AND MANUFACTURE DATES: 057419; EXP 03/01/2019; MFR DATE 04/16/2014. LOT 057452; EXP 03/01/2019; MFR DATE 04/18/2014. THE DHR WAS REVIEWED AND NO CORRELATION WAS FOUND BETWEEN MANUFACTURE OF PRODUCT AND EVENTS. SYNERGEYES HAS NEVER HAD AN OCCURRENCE OF THIS TYPE OF EVENT BEFORE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, SYNERGEYES RECEIVED A COMPLAINT WHEREIN A CONTACT LENS TECH (CLT) SUSTAINED A CUT TO HIS HAND FROM OPENING A VIAL. REPORT STATED: CLT WAS OPENING THE VIAL FOR THE 200 VAULT LENS FROM THE ULTRA HEALTH (UH) DIAGNOSTIC KIT TO FIT THE FIRST PATIENT WHEN THE TOP OF THE BOTTLE, BELOW THE NECK, CRACKED OFF IN CLT'S HAND AND THE RAW GLASS CUT HIS FINGER. ON (B)(6) 2014, SYNERGEYES LEFT A MESSAGE WITH (B)(4), AN OFFICE ATTENDANT FOR EYE ESSENTIALS INC. TO HAVE CLT CALL BACK. ON (B)(6) 2014, CLT CALLED BACK AND THE FOLLOWING INFORMATION WAS OBTAINED. ON (B)(6) 2014, THE CAP OF THE VIAL WAS NOT OPENING AND WHEN CLT APPLIED A LITTLE MORE TORQUE WITH HIS DOMINANT HAND, THE VIAL BROKE OFF BELOW THE NECK; SUCH THAT THE CAP, NECK, AND STOPPER BROKE OFF IN ONE PIECE. THE BROKEN GLASS CUT HIS RIGHT HAND. NO STITCHES OR ANY OTHER MEDICAL ATTENTION WAS NEEDED, ALL SYMPTOMS OF THE EVENT HAVE RESOLVED. THE VIAL AND ACCOMPANYING LENS HAVE BEEN DISPOSED OF AS RECOMMENDED BY THE SYNERGEYES REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364638 SYNERGEYES HYBRID CONTACT LENS CONTACT LENS HQD SYNERGEYES DUH20M-0650 056400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention