BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS GLAUCOMA FILTRATION DEVICE

    MDR report key: 17425053 · Received July 31, 2023

    Report

    Report Number
    3003701944-2023-00015
    Event Type
    Injury
    Date Received
    July 31, 2023
    Report Date
    September 29, 2023
    Manufacturer
    OPTONOL LTD.
    Product Code
    KYF
    PMA / PMN Number
    K012852
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. A SAMPLE WAS NOT RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE EVALUATED. 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 COULD NOT BE CONFORMED. COMPLAINT IS RELATED TO LITERATURE. MANUFACTURING SITE INVESTIGATIONS INCLUDE THE REVIEW AND INSPECTION OF THE TECHNICAL ASPECT OF THE COMPANY GFD (GLAUCOMA FILTRATION DEVICE) PRODUCT. REPORTED EVENT INCLUDES MAINLY RESULTS OF COMPANY GFD PRODUCT IMPLEMENTATION. ARTICLE DOES NOT EMPHASIZE THE TECHNICAL SCENARIOS OF EVENTS OR ISSUES RELATING SPECIFICALLY TO THE COMPANY PRODUCT. HOWEVER MAINLY MENTIONS THE DEVICE IMPLEMENTATION AS ONE OF THE GLAUCOMA TREATMENTS. NO DATA REGARDING PRODUCTS IDENTITY NOR PRODUCT SAMPLES WERE RECEIVED. DUE TO THE ABOVE, NO ADDITIONAL ACTION CAN BE EXECUTED BY MANUFACTURING SITE. ADDITION FOLLOW UP FOR RELATED EVENT CODES WILL BE MADE DURING THE ANNUAL POST PRODUCTION RISK REVIEW (PPRR). 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. LITERATURE: CREAGMILE J ET AL,HYDRUS MICROSTENT IMPLANTATION WITH OMNI SURGICAL SYSTEM AB INTERNO CANALOPLASTY FOR THE MANAGEMENT OF OPEN-ANGLE GLAUCOMA IN PHAKIC PATIENTS REFRACTORY TO MEDICAL THERAPY; AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS 29 (2023) 101749. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A LITERATURE ARTICLE PUBLISHED WITH A PURPOSE TO REPORT A SERIES OF 8 PHAKIC EYES OF 8 PATIENTS WITH OPEN ANGLE GLAUCOMA WITH UNCONTROLLED INTRAOCULAR PRESSURE ON MAXIMUM TOLERABLE MEDICAL THERAPY RECEIVING COMPANY MICROSTENT IMPLANTS COMBINED WITH CONCOMITANT OMNI SURGICAL SYSTEM AB INTERNO CANALOPLASTY. A 37-YEAR-OLD ASIAN MALE WITH JUVENILE OPEN ANGLE GLAUCOMA (JOAG) WAS REFERRED TO THE GLAUCOMA SERVICE FOR EVALUATION AND MANAGEMENT. IN THE OPERATIVE EYE, THE PATIENT HAD A PRE-TREATMENT MAXIMUM IOP OF 40 MMHG, AND EXAMINATION REVEALED C/D OF 0.9 WITH INFERIOR RIM THINNING. GONIOSCOPY WAS SIGNIFICANT FOR A 1 CLOCK HOUR PATCH OF INFERIOR PERIPHERAL ANTERIOR SYNECHIAE (PAS) INFERIORLY, AS WELL AS POSTOPERATIVE CHANGES FROM PREVIOUS GLAUCOMA SURGERY (DESCRIBED BELOW). HVF DEMONSTRATED AN MD OF - 17.53 DB, A PSD OF 11.73 DB, AND A DENSE SUPERIOR ARCUATE DEFECT. OCT (OPTICAL COHERENCE TOMOGRAPHY) REVEALED AN AVERAGE RNFL (RETINAL NERVE FIBER LAYER) THICKNESS OF 59M WITH A SUPERIOR THICKNESS OF 60M AND AN INFERIOR THICKNESS OF 57M. GANGLION CELL ANALYSIS (GCA)SHOWED A GLOBAL GANGLION CELL INNER PLEXIFORM LAYER (GCIPL) THICKNESS OF 64M. THE PATIENT HAD A PAST HISTORY OF TRABECULECTOMY AND IRIDECTOMY WITH MITOMYCIN C, WHICH SUBSEQUENTLY FIBROSED AND FAILED. THE PATIENT THEN UNDERWENT REPEAT TRABECULECTOMY WITH COMPANY SHUNT PLACEMENT WHICH AGAIN FAILED DUE TO AGGRESSIVE FIBROSIS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE COMPANY MODEL SHUNT TYPE. LITERATURE: CREAGMILE J ET AL,HYDRUS MICROSTENT IMPLANTATION WITH OMNI SURGICAL SYSTEM AB INTERNO CANALOPLASTY FOR THE MANAGEMENT OF OPEN-ANGLE GLAUCOMA IN PHAKIC PATIENTS REFRACTORY TO MEDICAL THERAPY; AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS 29 (2023) 101749.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660779 EX-PRESS GLAUCOMA FILTRATION DEVICE IMPLANT, EYE VALVE KYF OPTONOL LTD. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other