BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES HYBRID CONTACT LENS - AS

    MDR report key: 3916143 · Received June 6, 2014

    Report

    Report Number
    3005087645-2014-00013
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    March 28, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SYNERGEYES
    Product Code
    HQD
    PMA / PMN Number
    K051035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION THE FOLLOWING INFORMATION WAS OBTAINED: BASE CURVE MEASURED BY RADIUS SCOPE AND POWER MEASURED BY LENSMETER. BOTH BC AND POWER WIRE 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)(6) 2014, SYNERG EYES RECEIVED A COMPLAINT WHEREIN THE PATIENT SUSTAINED CORNEAL EROSION IN OD. REPORT STATED: THE PATIENT ORDERED NEW SETS OF LENSES IN EARLY (B)(6) AND SAW THE ECP ON (B)(6) 2014, COMPLAINING THAT THE OD CONTACT LENS HURT AFTER 1 TO 2 HOURS OF WEAR. ECP STATED THERE WERE NO FIT CHANGES FROM THE PREVIOUS YEAR AND THAT, WHEN EXAMINED, PT SHOWED EPITHELIAL STAINING IN AN ARC PATTERN. EYE-CARE PROFESSIONAL (ECP) ADVISED PATIENT TO STOP WEARING THE LENS AND PRESCRIBED ANTI-TEAR. PT WAS TO RETURN TO ECP PRACTICE IN 4 DAYS FOR FOLLOW-UP. PATIENT DID NOT RETURN FOR FOLLOW-UP UNTIL (B)(6) 2014. PT HAD DISCONTINUED USE OF LENSES FOR A WHILE, BUT RETURNED TO WEARING THEM PRIOR TO VISITING ECP AND HAD SAME PAINFUL REACTION TO THE LENSES. ECP STATES "CORNEA - SAME FINDING" PRESUMABLY FROM A REPEAT STAINING TEST. PT STATED THAT THIS ISSUE HAD OCCURRED LAST YEAR. ON (B)(6) 2014, SYNERGEYES CONTACTED (B)(6), AN OFFICE ATTENDANT FOR (B)(6), OD, PC AND OBTAINED THE FOLLOWING INFORMATION: PT HAD RECURRING DRY EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331436 SYNERGEYES HYBRID CONTACT LENS - AS CONTACT LENS HQD SYNERGEYES AS7585-0750 055561

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention