BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON

    MDR report key: 12930323 · Received December 4, 2021

    Report

    Report Number
    3012236936-2021-00107
    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 54.1 ± 6.4, 40¿67, 54.5 (MEAN ± SD, RANGE, MEDIAN), Y. SEX/GENDER: MALE 14 (53.9%), FEMALE 12 (46.1%). WEIGHT/ETHNICITY: INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: JULY-AUGUST 2019. 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, AHMED., BAYOUMI, N.H.L., FRCS (GLASGOW)., BADAWI, A.E., HAGRAS, S.M., ABDELKADER, A. (2019). INTRAVITREAL RANIBIZUMAB WITH PANRETINAL PHOTOCOAGULATION FOLLOWED BY TRABECULECTOMY VERSUS VISCO-TRABECULOTOMY IN MANAGEMENT OF NEOVASCULAR GLAUCOMA. ASIA-PACIFIC JOURNAL OF OPHTHALMOLOGY, 8(4), PP. 308¿313. 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: INTRAVITREAL RANIBIZUMAB WITH PANRETINAL PHOTOCOAGULATION FOLLOWED BY TRABECULECTOMY VERSUS VISCO-TRABECULOTOMY IN MANAGEMENT OF NEOVASCULAR GLAUCOMA. A STUDY WAS DONE TO COMPARE VISCO-TRABECULOTOMY (VT) WITH STANDARD TRABECULECTOMY WITH MITOMYCIN C (TRAB-MMC) IN THE TREATMENT OF QUIESCENT NEOVASCULAR GLAUCOMA (NVG). A TOTAL OF 51 EYES (27 RIGHT AND 24 LEFT) OF 51 PATIENTS WITH NVG UNDERWENT EITHER VT (N=26 EYES) OR TRAB-MMC (N=25 EYES). IN THE VT GROUP, THE SCHLEMM CANAL WAS INJECTED WITH HIGH VISCOSITY SODIUM HYALURONATE (HEALON GV, PFIZER). SUCCESS WAS DEFINED AS AN INTRAOCULAR PRESSURE OF =21MMHG AND WITHOUT VISION THREATENING COMPLICATIONS. FAILURE WAS NOTICED IN 4 EYES IN THE VT GROUP. COMPLICATIONS REPORTED IN THE VT GROUP INCLUDE HYPHEMA (N=22 EYES), FILTERING BLEB (N=3 EYES), SHALLOW ANTERIOR CHAMBER (N=1 EYE), TRANSIENT HYPOTONY (IOP <7 MM HG) (N=1 EYE), CHOROIDAL DETACHMENT (N=1 EYE), DESCEMET MEMBRANE SPLIT (N=8 EYES), INTRAOCULAR PRESSURE (IOP) SPIKE (N=4 EYES), AND PROGRESSION OF CATARACT (N=2 EYES). THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828554 HEALON AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB HEALON 0.55 UNKNOWN 15050474500065

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other