BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT

    MDR report key: 17240610 · Received June 30, 2023

    Report

    Report Number
    3012236936-2023-01647
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    December 24, 2020
    Report Date
    July 14, 2023
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    KYF
    PMA / PMN Number
    K905129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: IN REVIEW, IT WAS NOTICED THAT THE EVENT DESCRIPTION FOR THE PATIENT 12 ENTERED IN SECTION B5 OF THE INITIAL MDR REPORT WAS INADVERTENTLY NOT COMPLETE, WHICH THE COMPLETE INFORMATION HAS BEEN CAPTURED IN THIS SUPPLEMENTAL MDR REPORT AND THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION B5: 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A4 AND A5: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION B3: DATE OF EVENT: DEC 24, 2020 (THE DATE ARTICLE WAS ACCEPTED). SECTION D4: MODEL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: CATALOG NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. SECTION D4: EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D4: UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION D6A: IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. SECTION D6B: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE) THERE IS NO INDICATION THE DEVICE HAS BEEN EXPLANTED. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE SERIAL NUMBER FOR THIS DEVICE IS UNKNOWN/NOT PROVIDED; THEREFORE, NO FURTHER PRODUCT INVESTIGATION CAN BE PERFORMED. SHOULD ANY FURTHER RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: 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), FEBRUARY 2022. PP. 243-248. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, THE INFORMATION HAS NOT BEEN PROVIDED. 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 IN 2006 THEN UNDERWENT REVISION TWICE FOR EROSION THEN UNDERWENT REPLACEMENT WITH AN AHMED DRAINAGE DEVICE (NEW WORLD MEDICAL) IN 2018 BECAUSE OF HYPOTONY AND EROSION. THE PATIENT ALSO HAD RECURRENT ACUTE ANTERIOR UVEITIS IN THE RIGHT EYE SINCE PLACEMENT OF THE BAERVELDT DRAINAGE DEVICE IN 2006. 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 #13 FOR THE RIGHT EYE. SEPARATE REPORTS WILL BE SUBMITTED FOR THE LEFT EYE OF THE PATIENT #13 AND THE PATIENT #12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22212 UNK_GLAUCOMA SHUNT_BAERVELDT SHUNT IMPLANT, EYE VALVE KYF AMO MANUFACTURING NETHERLANDS UNK_GLAUCOMA SHUNT_BAERVELDT

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention