BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIESHABER DSP SURGICAL CONTACT LENS

    MDR report key: 17116009 · Received June 13, 2023

    Report

    Report Number
    3003398873-2023-00062
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    November 15, 2022
    Report Date
    July 20, 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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS REPORTED IN ERROR. THE REPORTED DEVICE USED DURING THE PROCEDURE IS USED ON THE ANTERIOR SURFACE OF THE EYE TO VISUALIZE FUNDUS AND RETINAL STRUCTURES DURING VITREORETINAL SURGERIES AND IS NOT USED IN THE INTERIOR OF THE EYE TO EXECUTE AND OR PERFORM A SURGICAL ACTION. THERE IS NO INDICATION THAT THE DEVICE CONTRIBUTED TO THE EVENT OR ANY ALLEGATION THAT OF A DEVICE MALFUNCTION OR DETERIORATION THE CHARACTERISTICS OR PERFORMANCE IN RELATION TO THE EVENT. THERE IS NO INDICATION OF DEVICE FAILURE AS THE DEVICE WAS USED AND PERFORMED AS INTENDED. THE EVENT "SUBCONJUNCTIVAL BLEEDING" DOES NOT MEET REPORTING CRITERIA AS PER APPLICABLE REGULATIONS BECAUSE THE INCIDENT DID NOT DIRECTLY OR INDIRECTLY LED TO A ¿TEMPORARY OR PERMANENT SERIOUS DETERIORATION OF A PATIENT'S, USER'S OR OTHER PERSON'S STATE OF HEALTH¿, AND ¿DID NOT RESULTED IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.¿. NO FURTHER REPORTS WILL BE REPORTED UNDER MFG REPORT NUM. 3003398873-2023-00062. 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

    THE INITIAL REPORT WAS REPORTED IN ERROR. AN INVESTIGATOR REPORTED IN A CLINICAL STUDY THAT WHILE USING A SURGICAL MACULAR LENS A PATIENT EXPERIENCED ¿SUBCONJUNCTIVAL BLEEDING AS LENS WAS RUBBING ON THE LIMBUS ¿ DURING A VITREORETINAL SURGERY. THE SYMPTOMS WERE RESOLVED. FOR THIS EVENT; THIS REPORT OF ¿SUBCONJUNCTIVAL BLEEDING¿ DOES NOT MEET REPORTING CRITERIA AS PER APPLICABLE REGULATIONS BECAUSE THE INCIDENT DID NOT DIRECTLY OR INDIRECTLY LED TO A ¿TEMPORARY OR PERMANENT SERIOUS DETERIORATION OF A PATIENT'S, USER'S OR OTHER PERSON'S STATE OF HEALTH¿, AND ¿DID NOT RESULTED IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE.¿

    Description of Event or Problem · 0

    AN INVESTIGATOR REPORTED IN A CLINICAL STUDY THAT AFTER USING A SURGICAL MACULAR LENS, A PATIENT EXPERIENCED SUBCONJUNCTIVAL BLEEDING AS LENS WAS RUBBING ON THE LIMBUS DURING SURGERY. THE SYMPTOMS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248298 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