BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES A LENS

    MDR report key: 16585826 · Received March 21, 2023

    Report

    Report Number
    3005087645-2023-00002
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    January 10, 2023
    Report Date
    March 20, 2023
    Manufacturer
    SYNERGEYES
    Product Code
    HQD
    UDI-DI
    M738A500060
    PMA / PMN Number
    K153714
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT C/O DISCOMFORT/SIGNIFICANT LENS AWARENESS. TRIED COMPLETION LENS SAME ISSUE. GPC REPORTED WITH BOTH LENSES SENT OS. ISSUE WITH OS LENS ONLY. NO ISSUES WITH PREVIOUS SYNERGEYES LENSES. REPLACING THE LENS ON THE 2ND LENS DID NOT RESOLVE ISSUE. ISSUE NOW RESOLVED WITH SCL USE. (3RD LENS REPLACEMENT). (B)(6) 2023 SPOKE WITH ECP, PT HAS NO HISTORY OF GPC OS (GIANT PAPILLARY CONJUCTIVITIS-USUALLY TERMED AS AN ALLERGIC REACTION). ECP: THE OD IS FINE NO SYMPTOMS OF GPC. PT TRIED 2 LENSES OS SAME ISSUE OCCURRED. PT IS USING B & L BIOTRUE TO CLEAN THE LENSES AND STORES IN CLEAR CARE AT NIGHT. PT INSERTED OS LENS, HE WAS UNABLE TO TOLERATE THE LENS, AND COULD NOT KEEP THE LENS IN HIS EYE. 1/25/23 SECOND LENS WAS ORDERED. SAME SYMPTOMS OCCURRED. THEY HAVE KEPT THE OD FIT, AND CANCELLED THE SYNERGEYES FIT OS (CREDIT ISSUED). PT NOW HAS SCL (B & L ULTRA FOR ASTIGMATISM) 1 MONTH MODALITY ON ORDER. PT WAS GIVEN LOTEMAX OPHTH. DROPS OS TWICE A DAY FOR 2 WEEKS. GPC RESOLVED POST USE. THIS RESOLVED THE GPC, GAVE PT COMFORT, & WAS USED AS PREVENTATIVE TREATMENT. HE IS NOW ON ZADITOR EVERY NIGHT AT BEDTIME AS PREVENTATIVE AND COMFORT. CONSULTATION DEPT. SYNERGEYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366306 SYNERGEYES A LENS DAILY WEAR HYBRID CONTACT LENS, PRODUCT CODE: HQD HQD SYNERGEYES AS7787-0900 107838 M738A500060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention