BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALON DUET

    MDR report key: 16721437 · Received April 11, 2023

    Report

    Report Number
    3012236936-2023-00747
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    March 9, 2023
    Report Date
    March 27, 2024
    Manufacturer
    AMO UPPSALA AB
    Product Code
    LZP
    PMA / PMN Number
    P810031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW, IT WAS NOTED THAT THE MODEL NUMBER 10-2900-80 IS INCORRECT. THE CORRECT MODEL NUMBER IS VT585U. FIELD BELOW IS UPDATED. SECTION D4: MODEL NUMBER: VT585U. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 5/1/2023. SECTION H3. DEVICE EVALUATED MANUFACTURER? YES. DEVICE EVALUATION: BASED ON THE PRODUCT RETURN EVALUATION, ALL SYRINGE CONNECTION COMPONENTS WERE PROPERLY SECURED TOGETHER AS DESIGNED. THERE IS NO EVIDENCE THAT THE SYRINGE RECEIVED AT LIFECORE AND OBSERVED DURING THE PRODUCT RETURN EVALUATION SHOULDN'T HAVE WORKED AS INTENDED AND DOES NOT MATCH THE ISSUE DESCRIPTION AS PRESENTED FROM THE CUSTOMER COMPLAINT. COMPLAINT REVIEW: AT THE TIME OF REVIEW, THERE WERE NO SIMILAR COMPLAINTS ASSOCIATED WITH LOT 029831. A REVIEW OF THE COMPLAINT DATABASE FOR THE LAST TWO YEARS FROM THE DATE OF AWARENESS INDICATES THERE HAS BEEN ONE OTHER POTENTIALLY SIMILAR COMPLAINTS RELATED TO ¿CANNULA PERFORMANCE¿ FOR ALL HEALON ENDOCOAT PRODUCTS IN THE J&J VISION PRODUCT LINE. BATCH RECORD REVIEW: THERE WERE NO DEVIATIONS OR COMMENTS ASSOCIATED WITH THE RECEIVING INSPECTION DOCUMENTATION FOR ANY OF THE RAW MATERIAL LOTS. THE LOTS WERE RELEASED FOR MANUFACTURING USE. A 100% INSPECTION OF SYRINGES WAS PERFORMED POST-FILL. THERE WERE NO REJECTS RELATED TO THE ALIGNMENT OR CONDITION OF THE LUER-LOK TIP CAP. NO COMMENTS OR DEVIATIONS WERE IDENTIFIED DURING RECORD REVIEW THAT WOULD HAVE LED TO THE IDENTIFIED COMPLAINT. CONCLUSION: NO ROOT CAUSE WAS IDENTIFIED. THIS COMPLAINT TYPE APPEARS TO BE ISOLATED TO THE SINGLE CANNULA FROM LOT 029831. LIFECORE WILL CONTINUE TO MONITOR AND TREND COMPLAINTS OF THIS TYPE. RECORD REVIEW DETERMINED COMPONENTS WERE AS INTENDED WHEN EVALUATED BY LIFECORE¿S ROUTINE RECEIVING INSPECTION. FINAL TESTING CONFIRMED THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. FINAL PRODUCT TESTING REQUIRES THE CONNECTION OF THE CANNULA TO THE SYRINGE FOR EXPELLING PRODUCT USED IN TESTING ACTIVITIES. THE OBSERVED BENT TIP IS UNRELATED TO THE ISSUE REPORTED BY CUSTOMER. THE REPORTED EVENT CANNOT BE CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D6A: IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE HEALON IS NOT AN IMPLANTABLE DEVICE. SECTION D6B: IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE HEALON IS NOT AN IMPLANTABLE DEVICE. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT 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, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ENDOCOAT CANNULA BURST INTO THE ANTERIOR CAPSULE CAUSING A TEAR. IT WAS STATED THAT CUSTOMER HAD AN ISSUE WITH THE 27G CANNULA (THAT COMES IN THE HEALON PACKAGE) LOCKING DOWN ON THE ENDOCOAT SYRINGE. THE CANNULA CAME OFF THE END OF THE ENDOCOAT. ALSO, CUSTOMER CONFIRMED THAT BY "CANNULA" THEY MEANT THAT THE PLASTIC THAT HOLDS THE NEEDLE FROM THE SYRINGE, FLEW OUT INTO THE ANTERIOR CAPSULE CAUSING A TEAR. IT WAS LEARNED THAT THERE WAS A RUPTURED ANTERIOR CAPSULE, CAUSING A RENT THAT EXTENDED CLOSE TO (BUT NOT PAST) THE EQUATOR. THE POSTERIOR CAPSULE WAS NOT VIOLATED. NO VITRECTOMY OR OTHER PROCEDURES NECESSARY. A LENS WAS PLACED SAFELY IN THE BAG, AND THE PATIENT HAD NO ISSUES POSTOPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257750 HEALON DUET AID, SURGICAL, VISCOELASTIC LZP AMO UPPSALA AB VT585U 029831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other