BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV PRO

    MDR report key: 15678529 · Received October 27, 2022

    Report

    Report Number
    3012236936-2022-02632
    Event Type
    Injury
    Date Received
    October 27, 2022
    Report Date
    November 10, 2022
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEX/GENDER: OUT OF 23 PATIENTS, 14 WERE MALE (60%) AND 9 WERE FEMALE (40%). DATE OF EVENT: THE STUDY WAS CONDUCTED BETWEEN JANUARY 2017 AND DECEMBER 2018 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. CITATION: BOCCUZZI, D.; PURVA, D.; ORFEO, V.; NAPOLITANO, P.; MULARONI, A.; IMBURGIA. A.; FORLINI, M. (2021). SUPPORTING IOL¿S IN ADEFICIENTCAPSULAR ENVIRONMENT: THE TALE OF NO ¿TAILS¿, JOURNAL OF OPHTHALMOLOGY, VOLUME 2021, ARTICLE ID 9933486, PP.1-7, HTTPS://DOI.ORG/10.1155/2021/9933486. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: THE HEALTH EFFECT - IMPACT CODE OF 4624 - SURGICAL INTERVENTION HAS BEEN REMOVED SINCE THE REPORT OF SMALL IRIDECTOMY PERFORMED IS NOT RELATED TO THE SUSPECTED PRODUCT. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: SUPPORTING IOL¿S IN ADEFICIENTCAPSULAR ENVIRONMENT: THE TALE OF NO ¿TAILS¿ A NONRANDOMIZED COMPARATIVE RETROSPECTIVE STUDY WAS DONE TO EVALUATE THE EFFICACY AND SAFETY OF THE FOLLOWING THREE DISTINCT SURGICAL PROCEDURES FOR SECONDARY INTRAOCULAR LENS (IOL) IMPLANTATION WITHOUT CAPSULAR SUPPORT: IRIS-CLAW LENS, FLANGED TRANSSCLERAL FIXATED IOLS (YAMANE TECHNIQUE), AND SUTURELESS TRANSSCLERAL HOOK IOL FIXATION (CARLEVALE IOL). A TOTAL OF 23 PATIENTS (N=24 EYES) WERE INCLUDED AND UNDERWENT CATARACT SURGERY. THEY WERE DIVIDED INTO THREE IMPLANTATION TECHNIQUES AFTER. GROUP 1 (N=13 EYES) IMPLANTED IRIS-CLAW LENSES (ARTISAN OPHTEC) IN THE ANTERIOR CHAMBER; GROUP 2 (N=6 EYES) HAD SUTURELESS INTRASCLERAL THREE-PIECE IOL (MA60MA, ALCON INC.) AND IN GROUP 3 USED TRANSSCLERAL IOL FIXATION WITH AN INTRASCLERAL PLUG USING CARLEVALE¿S IOL (CARLEVALE IOL, SOLEKO, ITALY). GROUP 1 HAD AN INJECTION OF SODIUM HYALURONATE 1.4% (HEALON GV, JOHNSON & JOHNSON VISION) FOR MAINTENANCE OF THE ANTERIOR CHAMBER ENDOTHELIAL PROTECTION AND TO FACILITATE IOL HANDLING AFTER THOROUGH ANTERIOR/POSTERIOR VITRECTOMY. AT THE END OF THE PROCEDURE, A SMALL IRIDECTOMY WAS PERFORMED, MAIN INCISION WAS SUTURED WITH 10/0 NYLON SUTURES AND HEALON WAS WASHED OUT FROM THE ANTERIOR CHAMBER. GROUP 3 TECHNIQUE HAD ITS SCLERAL FLAPS AND CONJUNCTIVAL WOUND SEALED WITH NYLON 10/0 AND POLYGLACTIN 8/0 (VICRYL), RESPECTIVELY COMPLICATIONS INCLUDED CORNEAL EDEMA SECONDARY TO RAISED INTRAOCULAR PRESSURE (N=4 EYES) WHICH LASTED OVER 7 DAYS (TRANSSCLERAL FLANGED GROUP, N=2 EYES; IRIS-CLAW GROUP, N=2 EYES) AND RESOLVED WITH TOPICAL ANTIGLAUCOMA THERAPY. CYSTOID MACULAR EDEMA (IRIS-CLAW GROUP, N=1 EYE) THAT REQUIRED NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) EYE DROPS AND WAS RESOLVED AFTER ONE MONTH OF TOPIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2454211 HEALON GV PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention