BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 16320290 · Received February 8, 2023

    Report

    Report Number
    3003701944-2023-00007
    Event Type
    Injury
    Date Received
    February 8, 2023
    Report Date
    April 18, 2023
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. LITERATURE REPORT: HIROAKI OZAKI ET. AL., CORNEAL OPACITY AFTER EXPRESS SHUNT, THE JAPAN GLAUCOMA SOCIETY ABSTRACTS, 2022: 33: P.97. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN H.3., H.6., AND H.10. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE EVALUATED. NO DATA REGARDING PRODUCT IDENTITY WAS RECEIVED I.E. NO LOT OR SERIAL NUMBER WERE INDICATED FOR THE EVENT THEREFORE A COMPLAINT HISTORY REVIEW, NON-CONFORMANCE REVIEW AND DHR REVIEW COULD NOT BE PERFORMED. NO SAMPLE RECEIVED: A ROOT CAUSE FOR THE CUSTOMERS REPORTED EVENT COULD NOT BE DETERMINED AS NO SAMPLE WAS RECEIVED AT INVESTIGATION SITE. NO SUPPORTING DATA WAS PRESENTED, OBTAINED OR IDENTIFIED WHILE INVESTIGATION CONCLUDING PRODUCT CONTRIBUTING FACTORS ARE RELATED TO THE EVENT. PRODUCT MALFUNCTION OR CAUSE COULD NOT BE DETERMINED WITH RELATION TO THE EVENT. RELATIONSHIP OF THE PRODUCT TO THE EVENT IS UNCLEAR. REPORTED EVENT CAN NOT BE CONFORMED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A STUDY WAS PUBLISHED WITH THE PURPOSE TO INVESTIGATE, ALTHOUGH THERE ARE SOME REPORTS OF POSTOPERATIVE CORNEAL ENDOTHELIAL DAMAGE AFTER COMBINED GLAUCOMA FILTRATION DEVICE (GFD) SURGERY, THERE ARE ALSO REPORTS THAT THERE IS LITTLE EFFECT ON THE CORNEAL ENDOTHELIUM, AND NO CONSENSUS HAS BEEN OBTAINED. IN THIS STUDY, WE REPORT ON CASES OF CORNEAL OPACITY AFTER GFD COMBINED FILTRATION SURGERY. THE PATIENTS UNDERWENT COMBINED GFD FILTRATION SURGERY FROM APRIL 2013 TO MARCH 2021. THE STUDY EXAMINED 316 EYES WITH OPEN-ANGLE GLAUCOMA THAT UNDERWENT COMBINED GFD FILTRATION SURGERY BETWEEN APRIL 2013 AND MARCH 2021, AND 4 EYES IN 4 CASES WITH CORNEAL OPACITY BY POSTOPERATIVE SLIT-LAMP MICROSCOPY. THE MEAN AGE WAS 76.5 YEARS (68-86 YEARS), AND ALL PATIENTS WERE MALE. IN THIS EYE, THE RESULTS STATED THAT, THE PREOPERATIVE CORNEAL ENDOTHELIAL CELLS DEVELOPED CORNEAL OPACITY WAS 957.5/MM2 (500-1544), AND THE MEAN TIME UNTIL CORNEAL OPACITY DEVELOPED POSTOPERATIVELY WAS 18.5 MONTHS (8-36 MONTHS). AT THE TIME OF CORNEAL OPACITY, CORNEAL ENDOTHELIAL CELLS HAD DECREASED TO LESS THAN 500/MM2. THE EYE HAD GFD REMOVED AFTER CORNEAL OPACITY. THE CORNEAL OPACITY WAS IMPROVING AND THE PATIENT FELT IMPROVEMENT IN SUBJECTIVE SYMPTOMS AFTER GFD REMOVAL. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 3 OF 4 EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175782 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. P-50 PL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O