BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV PRO

    MDR report key: 15687091 · Received October 27, 2022

    Report

    Report Number
    3012236936-2022-02660
    Event Type
    Injury
    Date Received
    October 27, 2022
    Report Date
    October 27, 2022
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE/DATE OF BIRTH: 47 PATIENTS, THE MEAN ± STANDARD DEVIATION AGE OF PATIENTS: VST GROUPS: 38.29 ± 12.5; MEDIAN 37 AND TRAB-OLOGEN: 38.91 ± 11.8 YEARS; MEDIAN: 38. SEX/GENDER: MALE (VST GROUPS: 11 AND TRAB-OLOGEN: 12), FEMALE (VST GROUPS: 13 AND TRAB-OLOGEN: 11). WEIGHT: INFORMATION UNKNOWN/NOT PROVIDED. ETHNICITY: INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2010 AND (B)(6) 2016 WHICH THE STUDY WAS CONDUCTED . MODEL NUMBER: UNKNOWN AS THE LOT NUMBER WAS NOT PROVIDED CATALOG NUMBER: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. LOT NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. IMPLANT DATE: N/A. HEALON IS NOT AN IMPLANTABLE DEVICE. EXPLANT DATE: N/A. HEALON IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT 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. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. CITATION: ELWEHIDY, A.S.; BAYOUMI, N.H.L.; NOKRASHY. A.E.; HAGRAS, S.M. (2022). LONG-TERM OUTCOMES OF TRABECULECTOMY WITH OLOGEN IMPLANT VERSUS COMBINED VISCOTRABECULOTOMY-SYNECHIOLYSIS IN UNCONTROLLED UVEITIC GLAUCOMA. INT OPHTHALMOL (2022) 42; PP. 411¿421. HTTPS://DOI.ORG/10.1007/S10792-021-02057-9. 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: LONG-TERM OUTCOMES OF TRABECULECTOMY WITH OLOGEN IMPLANT VERSUS COMBINED VISCOTRABECULOTOMY-SYNECHIOLYSIS IN UNCONTROLLED UVEITIC GLAUCOMA. A RETROSPECTIVE STUDY WAS DONE TO COMPARE TRABECULECTOMY WITH OLOGEN IMPLANT (TRAB-OLOGEN) TO COMBINED VISCOTRABECULOTOMY-SYNECHIOLYSIS (VTS) IN UNCONTROLLED UVEITIC GLAUCOMA (UG). A TOTAL OF 47 PATIENTS WITH MEDICALLY UNCONTROLLED GLAUCOMA (WITH SECONDARY SYNECHIAL ANGLE CLOSURE) SECONDARY TO CHRONIC UVEITIS HAD UNDERGONE EITHER VISCOTRABECULOTOMY SYNECHIOLYSIS (VTS) (N=24 EYES) OR TRABECULECTOMY WITH OLOGEN (TRAB-OLOGEN) (N=23 EYES). IN PATIENTS WHO UNDERWENT VTS, A HIGH VISCOSITY SODIUM HYALURONATE (HEALON GV; PFIZER) WAS SLOWLY INJECTED INTO BOTH ENDS OF SCHLEMM¿S CANAL THEN A SMALL AMOUNT OF SODIUM HYALURONATE WAS INJECTED THROUGH THE OPEN ENDS OF THE CANAL OF SCHLEMM AND ALONG THE TRABECULOTOMY OPENINGS, OVER THE ENTIRE CIRCUMFERENCE OF THE ANTERIOR CHAMBER ANGLE TO BREAK THE PAS (VISCOSYNECHIOLYSIS) AFTER WHICH A MINIMAL AMOUNT OF HEALON GV WAS ALSO LEFT INSIDE THE ANTERIOR CHAMBER WITHOUT WASH OUT HELPING TO TAMPONADE POTENTIAL HYPHEMA AND KEEPING THE ANGLE WIDE FOR THE FIRST FEW DAYS TO PREVENT PAS REFORMATION. IN THE VST GROUP, COMPLICATIONS INCLUDE HYPHEMA (N=20), DESCEMET¿S MEMBRANE DETACHMENT (PARTIAL) (N=4), SHALLOW ANTERIOR CHAMBER (N=1), FILTERING BLEB (N=2), AND PROGRESSION OF CATARACT (N=3). IN THE VST GROUP, 4 EYES WERE CLASSIFIED AS FAILURES BECAUSE OF THE NEED FOR A SUBSEQUENT GLAUCOMA OPERATION (N=2 EYES WERE IN NEED OF REPEAT GLAUCOMA SURGERY IN THE FORM OF TRABECULECTOMY WITH MITOMYCIN C (MMC), ONE EYE RECEIVED EX-PRESS (MODEL P50) DEVICE PLACEMENT AND THE LAST EYE UNDERWENT REPEAT VISCOTRABECULOTOMY, 180 DEGREES AWAY FROM THE SITE OF THE FIRST TRABECULOTOMY). IT WAS ALSO REPORTED THAT THE INTRAOCULAR PRESSURE (IOP) IN ONE EYE IN THE VST GROUP NEEDED A COMBINATION OF CARBONIC ANHYDRASE INHIBITOR AND BETABLOCKER DROPS TO BE CONTROLLED. MINOR FLARE-UPS (AT A RATE OF 2.5/YEAR) WERE CONTROLLED BY TOPICAL (THE MAJORITY CONTROLLED BY INCREASING THE FREQUENCY OF TOPICAL STEROIDS) OR SYSTEMIC (ONLY 2 CASES IN THE VST GROUP REVEALED SEVERE RELAPSE THAT REQUIRED TO INCREASE THE DOSE OF IMMUNOMODULATORY THERAPY) ANTI-INFLAMMATORY AGENTS. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2703858 HEALON GV PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention