BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 8844400 · Received July 31, 2019

    Report

    Report Number
    2648035-2019-00816
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    January 15, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531673
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE EVALUATION: THE RETURNED SAMPLE WAS RECEIVED. THE COMPLAINT PRODUCT WAS NOT RECEIVED IN ITS ORIGINAL PACKAGING. THE WHEEL CASE INSERTS, AND CARTRIDGE WERE IN THE BOX; HOWEVER, NO LENS WAS INSIDE THE PACKAGE. VISUAL INSPECTION REVEALED THAT THERE WAS NO LUBRICANT MATERIAL RESIDUES OBSERVED IN THE CARTRIDGE. STRESS MARKS CAN BE OBSERVED AT THE CARTRIDGE TIP WHICH IS TYPICALLY CAUSED BY THE PASS OF THE IOL THROUGH THE CARTRIDGE. NO LENS WAS RECEIVED FOR EVALUATION; THEREFORE, THE REPORTED ISSUES COULD NOT BE VERIFIED, AND PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MODEL ZCB00 INTRAOCULAR LENS (IOL) WAS DEFECTIVE WHILE INSERTING INTO THE EYE. IT WAS NOTED THAT THERE WAS ALSO INCISION ENLARGEMENT. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641967 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531673

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention