BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON

    MDR report key: 12930350 · Received December 4, 2021

    Report

    Report Number
    3012236936-2021-00108
    Event Type
    Injury
    Date Received
    December 4, 2021
    Report Date
    December 2, 2025
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    15050474500065
    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: AGE RANGE BETWEEN 17.4 ± 7.5 [7-31; 15] YEARS OF AGE. SEX/GENDER: MALE 8 (47.1), FEMALE 9 (52.9). WEIGHT/ETHNICITY: UNKNOWN, NOT PROVIDED. DATE OF EVENT: NOVEMBER 20, 2020. THE DATE ARTICLE WAS PUBLISHED. LOT NUMBER: INFORMATION UNKNOWN / NOT PROVIDED. EXPIRATION DATE: INFORMATION UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: N/A. THE OVD (OPHTHALMIC VISCOELASTIC DEVICE) HEALON GV IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: N/A. THE OVD (OPHTHALMIC VISCOELASTIC DEVICE) HEALON GV IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER OF THE COMPLAINT PRODUCT IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, THE COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. CONCLUSION: SINCE THE SAMPLE OF THE COMPLAINT PRODUCT WAS NOT RETURNED, AND LOT NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO DETERMINE A MALFUNCTION AND/OR PRODUCT QUALITY DEFICIENCY. ELWEHIDY, A., BAYOUMI, N., FRCS(GLASGOW)., ELSAYED, E., GHAFAR, A., ABDELKADER, A. (2020). SURGERY FOR GLAUCOMA IN PATIENTS WITH FACIAL PORT WINE MARK. FACULTY OF MEDICINE, MANSOURA UNIVERSITY. J AAPOS 24(6), 347.E1-6 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: SURGERY FOR GLAUCOMA IN PATIENTS WITH FACIAL PORT WINE MARK. A PROSPECTIVE STUDY WAS DONE TO REPORT ON THE LONG-TERM SURGICAL OUTCOMES OF COMBINED TRABECULOTOMY-TRABECULECTOMY WITH ANTIMETABOLITES IN THE TREATMENT OF STURGE-WEBER SYNDROME (SWS)-ASSOCIATED GLAUCOMA AND, SECONDARILY, TO COMPARE COMBINED VISCOTRABECULOTOMY-TRABECULECTOMY AND CLASSICAL TRABECULOTOMY-TRABECULECTOMY. A TOTAL OF 21 EYES (10 RIGHT AND 11 LEFT) WITH GLAUCOMA UNDERWENT COMBINED ANGLE AND FILTERING SURGERY WITH ANTIMETABOLITES EITHER CONVENTIONAL TRABECULOTOMY-TRABECULECTOMY (CTT) (N=11 EYES) OR VISCOTRABECULOTOMY-TRABECULECTOMY (VTT) (N=10 EYES). VTT WAS PERFORMED BY INJECTION OF HIGH-VISCOSITY SODIUM HYALURONATE HEALON GV (PFIZER) INTO THE SCHLEMM¿S CANAL PRIOR TO COMPLETION OF THE PROCEDURE WITH THE METAL TRABECULOTOME. AT THE END OF THE 2-YEAR FOLLOW-UP PERIOD, FAILURE OCCURRED IN 1 EYE IN THE VTT GROUP BASED ON ELEVATED INTRAOCULAR PRESSURE (IOP) AND A PROGRESSION OF OPTIC DISK CUPPING. COMPLICATIONS REPORTED IN THE VTT GROUP INCLUDE HYPHEMA (N=3 EYES), DESCEMET MEMBRANE DETACHMENT (N=1 EYE), TRANSIENT ELEVATION OF IOP (>21 MM HG) (N=4 EYES), AND CYSTIC BLEB (N=1 EYE). THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828559 HEALON AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB HEALON 0.55 UNKNOWN 15050474500065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown