BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES HYBRID CONTACT LENS

    MDR report key: 4013953 · Received June 20, 2014

    Report

    Report Number
    3005087645-2014-00015
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    March 20, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    PMA / PMN Number
    K083921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION WAS GIVEN BY ECP REGARDING WHICH LENSES CAUSED THE EDEMA, THEREFORE, WE WERE UNABLE TO PROVIDE MODEL NUMBER, LOT NUMBER AND EXPIRATION DATE NOR COULD WE PROVIDE THE MANUFACTURE DATE. PROBLEM LENSES NOT RETURNED, NO INSPECTION COULD BE PERFORMED. NOTE BY (B)(4), QUALITY ASSURANCE, REGULATORY AND CLINICAL AFFAIRS: "PER CALL (B)(4) 2014,: ECP REPORTS THAT SHE BELIEVES THE EDEMA AND GPC EXPERIENCED BY THE PATIENT ARE A THREAT TO THE PATIENT'S HEALTH AND CONSTITUTE AN INJURY." (B)(4) COMMENTS: CORNEAL EDEMA AND GPC ARE NOT SIGHT-THREATENING CONDITIONS AND OCCUR COMMONLY WITH ALL CONTACT LENSES. THEY WILL RESOLVE WITHOUT SEQUELAE AFTER CL IS REMOVED AND COULD HAVE BEEN CAUSED BY ALLERGY, LENSES, MULTIPURPOSE SOLUTION, OR A REACTION TO SOMETHING ELSE. REGARDLESS, THEY WOULD RESOLVE SPONTANEOUSLY WITH REMOVAL OF LENSES IF THE ETIOLOGY IS THE LENSES. NOT AN INJURY. HOWEVER, SINCE DOCTOR BELIEVES, FIRMLY, THAT THIS IS AN INJURY, FILE MDR.

    Description of Event or Problem · 1

    ON (B)(6) 2014, SYNERGEYES RECEIVED A COMPLAINT WHEREIN THE PATIENT (PT) SUSTAINED CORNEAL EDEMA ON RIGHT EYE (OD). REPORT STATED: PT HAD CORNEAL EDEMA WITH GIANT PAPILLARY CONJUNCTIVITIS (GPC) IN BOTH EYES (OU) DUE TO CONTACT LENS (CL) USE. ON (B)(6) 2014, SYNERGEYES CONTACTED DR. (B)(6) REGARDING PT AND THE FOLLOWING INFORMATION WAS OBTAINED: ON (B)(6) 2014, PT SAW ATTENDING EYE CARE PROFESSIONAL (ECP) COMPLAINING OF DISCOMFORT IN OU BUT GREATER PAIN IN OD. CORNEAL EDEMA FOUND IN OD DURING EXAMINATION. STEROID MEDICATION AND MURO 128 WERE PRESCRIBED. GPC SYMPTOMS RESOLVED WITH PRESCRIPTION OF MEDICATION. ECP BELIEVES CL TO BE CAUSE OF EDEMA AND THAT, "THE INJURY WAS DETRIMENTAL TO THE PATIENT'S HEALTH." NO RECORDED PRE-EXISTING CONDITIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. CUSTOMER DID NOT RETURN PROBLEM LENSES FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363702 SYNERGEYES HYBRID CONTACT LENS CONTACT LENS HQD SYNERGEYES, INC. SEE H-10 SEE H-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention