BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 9923496 · Received April 3, 2020

    Report

    Report Number
    2648035-2020-00319
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Report Date
    November 2, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474561755
    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

    SECTION D10. DEVICE AVAILABLE FOR EVALUATION? YES; RETURNED TO MANUFACTURER ON: 12/06/2019. SECTION H3. DEVICE RETURNED TO MANUFACTURER?: YES. DEVICE EVALUATION: THE PCB00V COMPLAINT SAMPLE WAS RECEIVED AT THE MANUFACTURING SITE WITH A DVD CONTAINING A VIDEO OF PORTIONS OF THE SURGERY. THE PCB00 INSERTION DEVICE WAS RECEIVED WITH THE PLUNGER FULLY ADVANCED LOCKED AND FUNCTIONAL. THERE ARE WHAT APPEARS TO BE TRACES OF VISCOELASTICS AND/OR BALANCED SALT SOLUTION IN THE DEVICE INDICATING IT WAS PREPARED FOR DELIVERY USING REQUIRED SURGERY AUXILIARIES. THERE IS NO ASSEMBLY DAMAGE ON THE PCB00 INSERTION DEVICE. THE QUALITY ENGINEER EVALUATED THE RETURNED INSERTION DEVICE AND OBSERVED THE PROVIDED VIDEO AND CONCLUDES THE FOLLOWING: BASED ON THE MANUFACTURING CONTROLS IN-PLACE AND THE REVIEW OF THE VIDEO PROVIDED, THE REPORTED COMPLAINT CANNOT BE CONFIRMED AS MANUFACTURING PROCESS RELATED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS AND RELATED DOCUMENTS FOR THE PRODUCTION ORDER OF THE DEVICE WERE REVIEWED AND NO DEVIATIONS OR NON-CONFORMANCE REPORTS ASSOCIATED TO THIS PO WERE FOUND. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO ADDITIONAL COMPLAINT HAS BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION 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

    CORRECTED DATA: IN REVIEW, IT WAS NOTED THAT THE DATE (4/2/2020) WAS INADVERTENTLY POPULATED IN THE SECTION ''B4'' OF THE INITIAL EMDR REPORT, WHICH IS INCORRECT. THE CORRECT DATE THAT SHOULD HAVE BEEN ENTERED IS 4/3/2020 WHICH IS CAPTURED IN THIS SUPPLEMENTAL REPORT. THE FOLLOWING FIELD WAS UPDATED ACCORDINGLY: SECTION B4: DATE OF THIS REPORT: 4/3/2020. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, MODEL PCB00V THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL PCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INJECTOR FAILURE OCCURRED DURING THE CATARACT SURGERY. ADDITIONALLY, IT WAS INDICATED THAT DURING THE LENS IMPLANT, SUBSTANCES WHICH LOOKED LIKE LUBRICATING OIL OR LUMPS CAME OUT. IT WAS INDICATED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE INTRAOCULAR LENS WITH A REPLACED CARTRIDGE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386453 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00V 05050474561755

    Patients

    Seq Age Sex Outcome Treatment
    1