BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON

    MDR report key: 12914788 · Received December 2, 2021

    Report

    Report Number
    3012236936-2021-00105
    Event Type
    Injury
    Date Received
    December 2, 2021
    Report Date
    December 4, 2025
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    5050474761421
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE (YEARS): 73.1 ± 9.1. PATIENT WEIGHT: INFORMATION UNKNOWN/ NOT PROVIDED. GENDER: 28 (52%). DATE OF EVENT: EXACT DATE NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS (B)(6) 2021. LOT NUMBER: INFORMATION UNKNOWN NOT PROVIDED. EXPIRATION DATE: UNKNOWN SINCE LOT NUMBER WAS NOT PROVIDED. UDI NUMBER: UNKNOWN SINCE LOT NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS HEALON GV IS NOT AN IMPLANTABLE DEVICE. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS HEALON GV IS NOT AN IMPLANTABLE DEVICE. THEREFORE, IT WAS NOT EXPLANTED. TELEPHONE NUMBER: UNKNOWN/ NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE LOT NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED AND THE REPORTED EVENT CANNOT BE CONFIRMED.. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD COULD NOT BE PERFORMED AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE LOT NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. CITATION: GILLMANN, K., AREF, A., NIEGOWSKI, J., L., BAUMGARTNER, JM., COMBINED AB INTERNO VISCOCANALOPLASTY (ABIC) IN OPEN-ANGLE GLAUCOMA: 12-MONTH OUTCOMES. (2021). INTERNATIONAL OPHTHALMOLOGY VOLUME 41, PP.3295¿3301. 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: COMBINED AB INTERNO VISCOCANALOPLASTY (ABIC) IN OPENANGLE GLAUCOMA: 12-MONTH OUTCOMES A RETROSPECTIVE STUDY WAS DONE TO ANALYZE THE SAFETY PROFILE AND EFFICACY OF AB INTERNO VISCOCANALOPLASTY (ABIC) FOR THE12 MONTH PERIOD POST-OPERATION. A TOTAL OF 41 OPEN-ANGLE GLAUCOMA PATIENTS (N=54 EYES) WERE INCLUDED IN THE STUDY, WHICH INVOLVED THE CATHETERIZATION OF SCHLEMM¿S CANAL WITH A FLEXIBLE MICROCATHETER THAT IS SUBSEQUENTLY WITHDRAWN WHILE COMPRESSED HEALON GV WAS STEADILY INJECTED TO VISCODILATE THE CANAL. INTRAOPERATIVE COMPLICATIONS INCLUDED: DESCEMET MEMBRANE DETACHMENT (N=2 EYES), IRIS TRAUMA (N=1 EYE). POSTOPERATIVE COMPLICATIONS INCLUDED: IOP SPIKES (N=12 EYES), SELF-RESOLVING ENDOTHELIAL BLOOD STAIN (N=1 EYE), IRIS ATROPHY (N=1 EYE), FIBRIN PLUG (N=1 EYE), ADDITIONAL GLAUCOMA SURGERY (N=7 EYES). ALL CASES CONSIDERED AS SURGICAL FAILURE (N=19 EYES) WERE ALL DUE TO UNCONTROLLED IOP WITH SOME REQUIRING FILTERING SURGERY (N=7 EYES). NO FURTHER INTERVENTIONS WERE REPORTED, NO FURTHER DETAILS PROVIDED. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816021 HEALON AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB HEALON GV UNKNOWN 5050474761421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention