BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALON PRO

    MDR report key: 19355701 · Received May 20, 2024

    Report

    Report Number
    3012236936-2024-000137
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 25, 2024
    Report Date
    October 29, 2024
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    UDI-DI
    04987617203481
    PMA / PMN Number
    P810031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: JUNE 14, 204. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES . DEVICE EVALUATION: FOUR UNITS WERE RETURNED INCLUDING THE SUSPECT PRODUCTS FOR THE REPORTS 3012236936-2024-0001371 AND 3012236936-2024-0001372. BELOW ARE THE INVESTIGATION RESULTS AND IT IS UNCLEAR WHICH ONE WAS THE REPORTED DEVICE. THE RETURNED SAMPLES CONSISTED OF 4 PRODUCT BOXES AND 4 FULLY ACTIVATED COMPLAINT SYRINGES EACH WITH A CANNULA AND PROTECTIVE SHEATH. THREE OF THE SYRINGES CONTAINED APPROXIMATELY 0.25ML OF EXPELLABLE HEALON SOLUTION IN THEM. THE FOURTH CONTAINED NO EXPELLABLE SOLUTION. THERE WERE NO SIGNS OF FIBER-LIKE PARTICLES IN THE REMAINING SOLUTIONS. THE CANNULAS WERE EXAMINED AND NO FIBERS OR SIMILAR MATERIAL WAS OBSERVED ON OR IN THE 4 COMPLAINT CANNULAS WHICH COULD EXPLAIN THE CUSTOMER'S NARRATIVE/OBSERVATION. NO PARTICLES OR ELONGATED THREAD-LIKE STRUCTURES WERE FOUND IN THE HEALON SOLUTIONS; THEREFORE, THE COMPLAINT NARRATIVE COULD NOT BE CONFIRMED. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATION. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION FOUND, AND NO ESCALATION WAS REQUIRED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2 AND A4: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6A - IMPLANT DATE: NOT APPLICABLE. HEALON IS NOT AN IMPLANTABLE DEVICE. SECTION D6B - EXPLANT DATE: NOT APPLICABLE. HEALON IS NOT AN IMPLANTABLE DEVICE. SECTION E1: EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3: THE DEVICE 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. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING THE INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE HEALON OPHTHALMIC VISCOSURGICAL DEVICE (OVD) DURING THE ANTERIOR CHAMBER INJECTION, AN ELONGATED THREAD WAS INJECTED FROM IT. THE PHYSICIAN REMOVED IT FROM THE PATIENT'S EYE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE BACKUP PRODUCT. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER DETAILS WERE PROVIDED. THIS OCCURRED TWICE AND A SEPARATE REPORT IS BEING SUBMITTED FOR THE OTHER INSTANCE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609563 HEALON PRO AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB TH85ML UM31624 04987617203481

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose