BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 17243658 · Received June 30, 2023

    Report

    Report Number
    3012236936-2023-01661
    Event Type
    Injury
    Date Received
    June 30, 2023
    Report Date
    June 30, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A4: PATIENT WEIGHT: UNKNOWN; REQUESTED BUT NOT PROVIDED. SECTION A5: RACE/ETHNICITY: UNKNOWN; REQUESTED BUT NOT PROVIDED. SECTION B3: DATE OF EVENT: (B)(6) 2022 (DATE THE ARTICLE WAS PUBLISHED). SECTION D4: MODEL NUMBER: UNKNOWN; REQUESTED BUT NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN; REQUESTED BUT NOT PROVIDED. SECTION D4: CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UNIQUE IDENTIFIER (UDI) NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: 2006. SPECIFIC DATE WAS REQUESTED BUT NOT PROVIDED. SECTION D6B: IF EXPLANTED, GIVE DATE: 2018. SPECIFIC DATE WAS REQUESTED BUT NOT PROVIDED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H3-OTHER (81):THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THERE WAS NO SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. LYONS LJ, MD, WU KY, MD, BARATZ KH, MD, SIT AJ, SM, MD,. HONEYCOMB EPITHELIAL EDEMA ASSOCIATED WITH RHO KINASE INHIBITION: A CASE SERIES AND REVIEW OF THE LITERATURE. CORNEA. 41(2), (B)(6) 2022. PP. 243-248. DOI: 10.1097/ICO.0000000000002694. AN ATTEMPTS WAS MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: HONEYCOMB EPITHELIAL EDEMA ASSOCIATED WITH RHO KINASE INHIBITION: A CASE SERIES AND REVIEW OF THE LITERATURE. A STUDY WAS DONE TO REPORT ON A SERIES OF 3 CASES OF CORNEAL CHANGES RELATED TO ROCK INHIBITORS NETARSUDIL (AND ITS SISTER DRUG RIPASUDIL) AND TO REVIEW THE CURRENT LITERATURE AND ALL ENGLISH LANGUAGE REPORTED INCIDENTS OF ¿HONEYCOMB¿ EDEMA ASSOCIATED WITH ROCK INHIBITORS. IN PATIENT 12 (63-YEAR-OLD WOMAN), THE PATIENT HAD A HISTORY OF BAERVELDT DRAINAGE DEVICE IMPLANTATION IN THE RIGHT EYE (OD) IN 2006 THEN UNDERWENT REPLACEMENT WITH AN AHMED DRAINAGE DEVICE (NEW WORLD MEDICAL) IN 2018 BECAUSE OF HYPOTONY. THE PATIENT ALSO HAD RECURRENT ACUTE ANTERIOR UVEITIS IN THE RIGHT EYE SINCE PLACEMENT OF THE BAERVELDT DRAINAGE DEVICE IN 2006 (QUIET WITH DAILY FLUOROMETHOLONE 0.25%), MARGINAL CORNEAL ULCER OD, AND RETINAL TEAR OD STATUS POST-LASER RETINOPEXY. THE PATIENT¿S BASELINE VISUAL ACUITY (VA) WAS 20/70 OD, WITH INTRAOCULAR PRESSURE (IOP) 20 MM HG OD ON BIMATOPROST 0.01% ONCE AT BEDTIME (QHS), DORZOLAMIDE 2% TWICE A DAY (BID), AND BRIMONIDINE-TIMOLOL 0.2% TO 0.5% BID. SLIT-LAMP EXAMINATION DEMONSTRATED STABLE INFERONASAL AND SUPERONASAL CORNEAL THINNING AND PANNUS OD. THE PATIENT WAS ADMINISTERED NETARSUDIL QHS OD FOR IOP REDUCTION. FOUR WEEKS LATER, THE PATIENT RETURNED FOR FOLLOW-UP AND WAS NOTED TO HAVE SYMPTOMATIC DECREASED VA OD OF 20/125 AND INCREASED IOP OF 33 MM HG. SLIT-LAMP EXAMINATION REVEALED ¿HONEYCOMB¿ EPITHELIAL EDEMA IN THE INFERONASAL CORNEA OD. BECAUSE OF THE POOR IOP RESPONSE AND DECLINE IN VA, NETARSUDIL WAS STOPPED, AND THE PATIENT UNDERWENT DIODE LASER CYCLOPHOTOCOAGULATION. THE CORNEAL EPITHELIAL FINDINGS RESOLVED WITHIN 4 WEEKS OF STOPPING NETARSUDIL. IN PATIENT 13 (22-YEAR-OLD WOMAN), THE PATIENT HAD A HISTORY OF BAERVELDT DRAINAGE DEVICE IMPLANTATION IN BOTH EYES IN 2015 AND A SECOND BAERVELDT DRAINAGE DEVICE WAS IMPLANTED IN THE LEFT EYE IN 2019. SLIT-LAMP EXAMINATION REVEALED THAT THE TUBE SHUNT WAS IN GOOD POSITION IN THE ANTERIOR CHAMBER (AWAY FROM THE CORNEA) WITH DIFFUSE EPITHELIAL EDEMA IN THE RIGHT EYE. THE PATIENT WAS STARTED ON NETARSUDIL ON BOTH EYES FOR THE ELEVATED INTRAOCULAR PRESSURE (IOP). A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. THIS REPORT PERTAINS TO PATIENT #12 FOR THE RIGHT EYE. SEPARATE REPORTS WILL BE SUBMITTED FOR PATIENT #13 RIGHT EYE AND LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254255 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention