BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE PACK, DISPOSABLE TUBING

    MDR report key: 8368610 · Received February 25, 2019

    Report

    Report Number
    3006695864-2019-00161
    Event Type
    Injury
    Date Received
    February 25, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474534445
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED THAT INDICATED THE CAPSULAR TEAR REPORTED DID NOT REQUIRE A VITRECTOMY PROCEDURE AND POST OP PATIENT OUTCOME WAS WELL. DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. DEVICE INSPECTION COULD NOT BE PERFORMED, THEREFORE THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT, NO RELATED NON-CONFORMITY OR DEVIATIONS WERE ISSUED DURING MANUFACTURING THE TUBING PACK MODEL NO. OPO71, LOT# 60139731. ALL DEVICES MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN AS IT WAS NOT PROVIDED. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION PROCEDURE, THE SURGERY REPORTED TWO PATIENTS HAD CAPSULAR TEAR OCCUR IN THE OPERATIVE EYE WHEN USING THE OPO71 DISPOSABLE TUBING PACK. A DESCRIPTION FROM THE SURGERY CENTER INDICATED OUT OF 7 CASES, THEY HAD 2 CAPSULAR TEARS AND IN 2 OTHER CASES, THEY HAD UNSTABLE CHAMBER. IT IS UNKNOWN IF THERE WAS SURGICAL OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH SEVERAL ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 1 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160020 SIGNATURE PACK, DISPOSABLE TUBING PHACO TUBING HQC JOHNSON & JOHNSON SURGICAL VISION, INC. OPO71 60139731 05050474534445

    Patients

    Seq Age Sex Outcome Treatment
    1 Other