BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIESHABER DSP SURGICAL CONTACT LENS

    MDR report key: 17190309 · Received June 23, 2023

    Report

    Report Number
    3003398873-2023-00084
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    April 1, 2023
    Report Date
    September 6, 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
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    THE NON-CONFORMANCE INVESTIGATION (NCI) OPENED DUE TO MONITORING ACTIVITIES OF COMPLAINT NUMBERS IN EARLY JUNE 2023 CONFIRMED THAT THIS COMPLAINT IS RELATED TO A POST MARKET CLINICAL FOLLOW-UP (PMCF) STUDY. THE PMCF STUDY FACILITATED A QUESTIONNAIRE, WHICH FOCUSED ON ASSESSING PROCEDURAL SUCCESS OF THE DEVICES UNDER EVALUATION. A NUMBER OF NEGATIVE RESPONSES (I.E., ADVERSE EVENTS) WAS RECEIVED, WHICH WERE TRANSLATED INTO COMPLAINTS. DUE TO THE NATURE OF THE QUESTIONNAIRE, INFORMATION REQUIRED TO PERFORM A PROPER COMPLAINT INVESTIGATION WAS NOT COLLECTED. 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. WITHIN THE FRAMEWORK OF THE MENTIONED NCI, AN OVERALL RISK ASSESSMENT WAS PERFORMED AND CONCLUDED THAT NO FURTHER ACTIONS ARE REQUIRED. ADDITIONALLY, COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ADVERSE TRENDS. NO ADDITIONAL ACTIONS ARE NEEDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A CLINICAL SURVEY REVEALED THAT AFTER VITRECTOMY SURGERY A FEMALE PATIENT EXPERIENCED WITH MILD HYPEREMIA. UNKNOWN INTERVENTION WAS PERFORMED TO TREAT THE PATIENT. CURRENT PATIENT SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855545 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