BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON GV

    MDR report key: 20993292 · Received December 20, 2024

    Report

    Report Number
    3012236936-2024-000328
    Event Type
    Injury
    Date Received
    December 20, 2024
    Report Date
    December 20, 2024
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE ACCEPTANCE DATE IS AUGUST 20, 2023. IT DOES NOT CONTAIN INFORMATION AS TO WHEN THE SURGERIES WERE CONDUCTED. SECTION D4 - EXPIRATION DATE: UNKNOWN, AS PRODUCT LOT NUMBER WAS NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3: THE HEALON GV PRO WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4 - DEVICE MANUFACTURE DATE: UNKNOWN, AS PRODUCT LOT NUMBER WAS NOT PROVIDED. CITATION: OREJUDO DE RIVAS, M.; MARTÍNEZ MORALES, J.; PARDINA CLAVER, E.; PÉREZ GARCÍA, D.; PÉREZ NAVARRO, I.; ASCASO PUYUELO, F.J.; ARAMBURU CLAVERÍA, J.; IBÁÑEZ ALPERTE, J. DESCEMET¿S MEMBRANE DETACHMENT DURING PHACOCANALOPLASTY: CASE SERIES AND IN-DEPTH LITERATURE REVIEW. J. CLIN. MED. 2023, 12, 5461. 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: DESCEMET'S MEMBRANE DETACHMENT DURING PHACOCANALOPLASTY: CASE SERIES AND IN-DEPTH LITERATURE REVIEW. A STANDARD AB EXTERNO SC SURGERY, KNOWN AS CANALOPLASTY AB EXTERNO, AND A STANDARD PHACOEMULSIFICATION AND A POSTERIOR CHAMBER INTRAOCULAR LENS (ACRYSOF IQ IOL, ALCON®, GENEVA, SWITZERLAND) IMPLANTATION WERE PERFORMED. THE PRIMARY CORNEAL INCISION WAS SUTURED USING 10/0 NYLON. AN OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WITH VISCOADAPTATIVE PROPERTIES (HEALON GV; JOHNSON AND JOHNSON, NEW BRUNSWICK, NJ, USA) WAS INJECTED THROUGH THE SC OPENING ON BOTH SIDES. THE CANAL WAS PROBED 360 USING A MICROCATHETER (ITRACK®; NOVA EYE MEDICAL, ADELAIDE, AUSTRALIA). DURING THE RETRACTION OF THE CATHETER, OVD WAS INJECTED EVERY 2 CLOCK HOURS TO DILATE THE CANAL. INTRAOPERATIVELY, WHILE RETRACTING THE CATHETER, AT THE 6 O¿CLOCK POSITION, A DMD WAS OBSERVED, ACCOMPANIED BY SIGNIFICANT BLOOD LEAKAGE MIXED WITH VISCOELASTIC MATERIAL IN THE LOWER QUADRANTS (INFERONASAL AND INFEROTEMPORAL QUADRANTS IN CASE 1, INFEROTEMPORAL QUADRANT IN CASES 2 AND 3), RESEMBLING A POSSIBLE MICRO-RUPTURE OF THE TRABECULAR MESHWORK. IN THE THIRD CASE, INTRAOPERATIVE MANAGEMENT INVOLVED DRAINING THE DMD WITH A 30-GAUGE NEEDLE AND INTRACAMERAL AIR INJECTION. SUTURING WAS ALSO DONE. THE ANTERIOR CHAMBER WAS REFORMED WITH A BALANCED SALT SOLUTION, AND AN AIR BUBBLE WAS LEFT TO OCCUPY THE ENTIRE ANTERIOR CHAMBER (AC). THE CONJUNCTIVA WAS CLOSED USING A NON-ABSORBABLE SUTURE (8/0 SILK). SERIOUS INJURY: YES. DEVICE MALFUNCTION: UNKNOWN. INTERVENTIONS: YES. AFTER A 24-H POSTOPERATIVE ASSESSMENT, BMC (BIO-MICROSCOPY) EXAMINATION SHOWED CORNEAL STROMAL EDEMA AND HEMORRHAGIC DESCEMET MEMBRANE DETACHMENT (HDMD) IN THE LOWER TEMPORAL SECTOR, MEASURING APPROXIMATELY 4 × 4 MM IN DIAMETER. THE HDMD DID NOT AFFECT THE VISUAL AXIS, AND AN AIR BUBBLE WAS OBSERVED IN THE UPPER AC (ANTERIOR CHAMBER). THE IOP MEASURED AT THIS TIME WAS 17 MMHG. IN CASE 2, THE HDMD UNDERWENT OXIDATION, RESULTING IN A RESIDUAL PRE- DESCEMETIC INTRACORNEAL ORANGE SPOT. HOWEVER, THIS SPOT DID NOT HAVE ANY IMPACT ON VISION, AND THE BCVA AFTER 3 MONTHS WAS 1. A STRATEGY OF WATCHFUL WAITING WAS DEEMED APPROPRIATE DUE TO THE LOCATION AND SIZE OF THE DMDS, AS THEY DID NOT AFFECT THE BEST-CORRECTED VISUAL ACUITY (BCVA). A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2311481 HEALON GV AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TG85ML UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other| R