BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES HYBRID CONTACT LENS - KS

    MDR report key: 3883639 · Received June 9, 2014

    Report

    Report Number
    3005087645-2014-00014
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    March 20, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SYNERGEYES
    Product Code
    HQD
    PMA / PMN Number
    K051035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECOND DEVICE RETURNED: MODEL # KS6785-1550, LOT #: 052049, EXPIRATION DATE: 06/01/2018, MANUFACTURE DATE: 07/01/2013. DURING THE INVESTIGATION, THE FOLLOWING INFORMATION WAS OBTAINED. DEVICE 1: BASE CURVE MEASURED BY RADIUS SCOPE AND POWER MEASURED BY LENSOMETER, BOTH BC AND POWER WERE FOUND TO BE WITHIN SPECIFICATIONS. NO DEFECTS WERE NOTED ON SURFACE AND NO CORRELATION WAS FOUND BETWEEN THE ALLEGED INJURY AND THE LENS PROCESSING HISTORY. DEVICE 2: BASE CURVE MEASURED BY RADIUS SCOPE AND POWER MEASURED BY LENSOMETER. BOTH BC AND POWER WERE FOUND TO BE WITHIN SPECIFICATIONS. NO DEFECTS WERE NOTED ON SURFACE AND NO CORRELATION WAS FOUND BETWEEN THE ALLEGED INJURY AND THE LENS PROCESSING HISTORY.

    Description of Event or Problem · 1

    ON (B)(4) 2014, SYNERGEYES RECEIVED A COMPLAINT WHEREIN PT SUSTAINED A CORNEAL ULCER IN THE RIGHT EYE (OD). PT ALSO EXPERIENCED "SLIGHT IRRITATION." ATTENDING EYE-CARE PROFESSIONAL (ECP) PRESCRIBED TOBRADEX FOR SYMPTOMS IN THE LEFT EYE (OS). COMPLAINT STATES THAT SYMPTOMS SURFACED (B)(6) 2014, HOWEVER "ALL SYMPTOMS HAVE BEEN RESOLVED AS OF NOW." WHEREIN, "NOW" REFERS TO (B)(6) 2014. FROM (B)(6) 2014, SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL EVENT INFORMATION FROM ECP. ON (B)(6) 2014, SYNERGEYES SPOKE WITH DR (B)(6) REGARDING THE EVENT AND PT. THE FOLLOWING WAS DISCLOSED: PT HAS A HISTORY OF OVER WEARING LENSES. FOR EXAMPLE: PT WORE LAST SET OF SYNERGEYES LENS FOR LONGER THAN ONE YEAR, WHEN THE RECOMMENDED LENGTH IS 6 MONTHS, THE LENSES MENTIONED WERE ORDERED (B)(6) 2009. NEW LENSES ORDERED IN THE SAME PARAMETERS ON (B)(6) 2014 WERE UNCOMFORTABLE FOR PT AND PT DEVELOPED REDNESS AND IRRITATION WITH PAIN GREATER IN OD THAN IN OS. AT A FOLLOW UP VISIT, PT EXHIBITED A "MECHANICAL" STERILE ULCER IN THE RIGHT EYE JUST OUTSIDE THE JUNCTION. THIS CLEARED COMPLETELY WITH TREATMENT. A TECHNICIAN FROM THE ECP PRACTICE CALLED SYNERGEYES CONSULTATION ON (B)(6) 2014 AND INQUIRED ABOUT OS LENS TURNING EYE "RED." SYNERGEYES CONSULTANT INSTRUCTED LAB TECH TO SWITCH LENSES TO SEE IF PROBLEM FOLLOWED LENS TO OD OR REMAINED ONLY IN OS. AS INSTRUCTED BY DR (B)(6) THIS WAS NEVER DONE. INSTEAD, DR (B)(6) RETURNED LENSES AND REORDERED THE SAME PRESCRIPTION (RX) FOR BOTH EYES, TO VERIFY IF ORIGINAL LENSES WERE "BAD". OS RX WAS ORDERED ON (B)(6) 2014 AND OD RX ON (B)(6) 2014. PT IS DOING WELL WITH NEW LENSES FOR BOTH EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334142 SYNERGEYES HYBRID CONTACT LENS - KS CONTACT LENS HQD SYNERGEYES KS6785-1450 056131

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention