BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAM FLW SLEV&TST CHAM

    MDR report key: 8455276 · Received March 27, 2019

    Report

    Report Number
    3006695864-2019-00250
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Report Date
    November 10, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 (B)(4) AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ALTHOUGH THE SLEEVE/TEST CHAMBER OF THE TIP WAS NOT RETURNED, THE PARTICLE THAT MAY HAVE CAUSED THE CLOGGED TIP WAS RETURNED. A WHITE PARTICLE WAS RECEIVED WITHIN A PLASTIC CONTAINER FIXED IN PLACE WITH OFFICE TAPE. MATERIAL ANALYSIS RESULTS: TWO SEPARATE MEASUREMENTS OF THE FTIR (COMPONENT ANALYSIS) SPECTRUM FOR THE WHITE PARTICLE WERE OBTAINED AND THE EXCELLENT OVERLAP BETWEEN THE SPECTRA CONFIRMS THE HOMOGENEITY OF THE MATERIAL. FTIR ANALYSIS INDICATES THE MATERIAL IS CONSISTENT WITH ACRYLONITRILE/BUTADIENE/STYRENE (ABS) BY COMPARISON WITH A REFERENCE. ABS IS A COMMON THERMOPLASTIC POLYMER. MANUFACTURING RECORD AND COMPLAINT HISTORICAL REVIEW: A REVIEW OF THE MANUFACTURING RECORDS AND COMPLAINT HISTORICAL REVIEW COULD NOT BE PERFORMED AS A PRODUCT LOT NUMBER WAS NOT PROVIDED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. MULTIPLE FACTORS COULD CONTRIBUTE TO THE REPORTED EVENT, INCLUDING BUT NOT LIMITED TO, OPERATIONAL ENVIRONMENT. DUE TO THE CONDITION OF THE RETURNED PARTICLE AND INFORMATION OBTAINED, IT WAS UNABLE TO DETERMINE THE EXACT CAUSE. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    DURING A CATARACT PROCEDURE, THE PHACO TIP BECAME OCCLUDED/CLOGGED. A DESCRIPTION FROM THE SURGERY CENTER REPORTED THAT FOREIGN MATERIAL WAS OBSERVED DURING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. THIS IS 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248467 LAM FLW SLEV&TST CHAM PHACO ACCESSORY HQC JOHNSON & JOHNSON SURGICAL VISION, INC. OPOHF20L UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1