BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIESHABER DSP SURGICAL CONTACT LENS

    MDR report key: 17223399 · Received June 29, 2023

    Report

    Report Number
    3003398873-2023-00161
    Event Type
    Injury
    Date Received
    June 29, 2023
    Date of Event
    March 1, 2023
    Report Date
    September 14, 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
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO LOT NUMBER WAS IDENTIFIED WITHIN THE STUDY AND THEREFORE WITHIN THIS COMPLAINT, WHICH IS WHY THE ASSOCIATED MANUFACTURING DOCUMENTATION COULD NOT BE REVIEWED. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE, ENSURING THAT ALL PRODUCTS ON THE MARKET FULFILL THE RELEVANT REQUIREMENTS. SINCE THE QUESTIONNAIRE RETROSPECTIVELY COLLECTS DATA, NO SAMPLE IS AVAILABLE TO BE PROVIDED TO THE RESPONSIBLE SITE FOR AN IN-DEPTH INVESTIGATION. NOT ENOUGH INFORMATION WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE IDENTIFIED. THE EXACT ROOT CAUSE FOR THE CUSTOMER¿S REPORTED EVENT IS UNKNOWN. THEREFORE, NO SPECIFIC ACTION CAN BE TAKEN. 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 REPORTED RECEIVED VIA CLINICAL STUDY THAT OPHTHALMIC SURGICAL CONTACT LENS USED FOR THE VITREORETINAL SURGERY AFTER THE SURGERY PATIENT EXPERIENCED INFLAMMATION, IRRITATION FOR WHICH THE EVENT REQUIRED INTERVENTION (UNKNOWN IF SURGICAL OR MEDICAL). THE SYMPTOMS ARE IMPROVING. NO FURTHER INFORMATION EXPECTED AS THE DETAILS WERE RECEIVED FROM A CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562469 GRIESHABER DSP SURGICAL CONTACT LENS LENS, FUNDUS, HRUBY, DIAGNOSTIC HJI ALCON GRIESHABER AG NA ASKU 07612717071285

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O VOLK SINGLE-USE LENSES