BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGEYES A EP LENS

    MDR report key: 22508965 · Received July 15, 2025

    Report

    Report Number
    3005087645-2025-00001
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 11, 2025
    Manufacturer
    SYNERGEYES, INC.
    Product Code
    HQD
    UDI-DI
    M738A500060
    PMA / PMN Number
    K153714
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    06/13/2025: COMPLAINT RECEIVED AT SYNERGEYES. 06/24/2025: COMPLAINT WAS PROCESSED, RMA CREATED AND SENT TO QA AND CONSULTATION FOR FURTHER EVALUATION. 06/24/2025: (B)(6) INSPECTED: FOUND SCRATCHES AND SMUDGES AT SURFACE INSPECTION, NO TEARS OR CRACKS FOUND. PARAMETERS MEASURED ARE WITHIN VIAL LABEL SPECIFICATIONS. SCRATCHES AND SMUDGES ARE CONSISTENT WITH CARE AND HANDLING. 07/01/2025: CONSULTATION DEPARTMENT HAS NOT BEEN ABLE TO GET MORE DETAILS FROM ECP. WILL REACH OUT AGAIN. 07/11/2025: CONSULTATION DEPARTMENT RECEIVED VOICE MAIL FROM OFFICE STAFF STATING THEY WERE LEAVING ON VACATION. STATING THAT THE POTENTIAL INJURY (ABRASION) WAS CAUSED BY THE PATIENT INSERTING A TORN LENS AND THEN WEARING THE LENS. THEY DO NOT FEEL THE LENS PRODUCT IS AT FAULT, (MORE PT HANDLING). DR. (B)(6) PRESCRIBED TOBRADEX (COMBINATION ANTIBIOTIC/ STEROID) DROPS FOR 7 DAYS OD ONLY, FOUR TIMES A DAY. ALL SYMPTOMS HAVE RESOLVED AT THIS TIME. ALTHOUGH THE PATIENT IS DOING WELL NOW, SYNERGEYES HAS DECIDED TO FILE AT THIS TIME TO BE ON THE SAFE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146101 SYNERGEYES A EP LENS DAILY WEAR HYBRID CONTACT LENS HQD SYNERGEYES, INC. AS7383-0500CT 123217 M738A500060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention