BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIESHABER DSP SURGICAL CONTACT LENS

    MDR report key: 17116111 · Received June 13, 2023

    Report

    Report Number
    3003398873-2023-00063
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    February 15, 2023
    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

    CORRECTED INFORMATION PROVIDED IN SECTION B.2, B.5, H.6 AND H.10. THE INITIAL REPORT WAS REPORTED IN ERROR. THIS EVENT OF "POOR MACULAR VISUALIZATION" DURING SURGERY WHILE USING A MACULAR LENS DOES NOT MEET REPORTING CRITERIA BECAUSE THE PRODUCT ¿DID NOT DIRECTLY OR INDIRECTLY LED, MIGHT HAVE LED, OR MIGHT LEAD TO ANY OF THE FOLLOWING: (A) THE DEATH OF A PATIENT, USER OR OTHER PERSON, (B) THE TEMPORARY OR PERMANENT SERIOUS DETERIORATION OF A PATIENT'S, USER'S OR OTHER PERSON'S STATE OF HEALTH. THERE IS NO INDICATION THAT REASONABLY SUGGESTS THE DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY ON RE OCCURRENCE. 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. NO FURTHER REPORTS WILL BE REPORTED UNDER MFG REPORT NUM. 3003398873-2023-00063. 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. THE CORRECT REPORTED EVENT REPORTED VIA CLINICAL STUDY IS FOR ¿POOR MACULAR VISUALIZATION¿ DUE TO BEING A COMBINED SURGERY. ALSO, IT WAS INDICATED A HISTORY OF CORNEAL EDEMA WAS DUE TO PREVIOUS PHACOEMULSIFICATION (PHACO) SURGERY AND POOR PATIENT COLLABORATION. THIS EVENT OF POOR MACULAR VISUALIZATION DURING SURGERY WHILE USING A MACULAR LENS DOES NOT MEET REPORTING CRITERIA BECAUSE THE PRODUCT ¿DID NOT DIRECTLY OR INDIRECTLY LED, MIGHT HAVE LED, OR MIGHT LEAD TO ANY OF THE FOLLOWING: (A) THE DEATH OF A PATIENT, USER OR OTHER PERSON, (B) THE TEMPORARY OR PERMANENT SERIOUS DETERIORATION OF A PATIENT'S, USER'S OR OTHER PERSON'S STATE OF HEALTH. THERE IS NO INDICATION THAT REASONABLY SUGGESTS THE DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY ON RE OCCURRENCE. 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.

    Description of Event or Problem · 0

    AN INVESTIGATOR REPORTED IN A CLINICAL STUDY THAT WHILE USING A SURGICAL MACULAR LENS DURING A VITREO RETINAL PROCEDURE A PATIENT EXPERIENCED WITH POOR MACULAR VISUALIZATION AND CORNEAL EDEMA DUE TO PREVIOUS PHACOEMULSIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207586 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