BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIESHABER DSP SURGICAL CONTACT LENS

    MDR report key: 17116308 · Received June 13, 2023

    Report

    Report Number
    3003398873-2023-00064
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    January 1, 2023
    Report Date
    July 18, 2023
    Manufacturer
    ALCON GRIESHABER AG
    Product Code
    HJI
    UDI-DI
    07612717071285
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED FOLLOWING SUBMISSION OF THE INITIAL REPORT, IT WAS CLARIFIED THAT THE ADVERSE EVENT EXPERIENCED BY THE PATIENT IS UNRELATED TO THE OPHTHALMIC DISPOSABLE PRODUCT REPORTED IN THE FILE. NO FURTHER REPORTS WILL BE SCHEDULED UNDER MFG REPORT NUM. 3003398873-2023-00064. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED VIA A CLINICAL STUDY THAT DURING A VITRECTOMY SURGERY WHILE USING AN OPHTHALMIC DISPOSABLE PRODUCT A PATIENT EXPERIENCED RETINAL DETACHMENT AND RECURRENT BLEEDING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171413 GRIESHABER DSP SURGICAL CONTACT LENS LENS, FUNDUS, HRUBY, DIAGNOSTIC HJI ALCON GRIESHABER AG NA ASKU 07612717071285

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other