BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL

    MDR report key: 11256954 · Received February 1, 2021

    Report

    Report Number
    2648035-2021-00026
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Report Date
    February 26, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS IS TO CORRECT INITIAL VMSR#, FOR MODEL DCB00V. UPON FURTHER REVIEW OF SERIAL# (B)(6), IT WAS DISCOVERED, THAT IT BELONGS TO MODEL DCB00V AND NOT DCB00 AS INITIALLY REPORTED IN VMSR 2648035-2021-00012. THEREFORE, THE INITIAL VMSR#, FOR MODEL DCB00V INCORRECTLY REPORTED <NOE> 15 </NOE>, BECAUSE IT WAS MISSING SERIAL# (B)(6). THE CORRECT INFORMATION IS <NOE> 16 </NOE>. BREAKDOWN OF EVENTS FOR LENS DAMAGED = 15. SECTION D4: SERIAL NUMBER OF THE SUSPECT PRODUCT: (B)(6). ONE INVESTIGATION WAS PENDING. THAT IS FOR SERIAL # (B)(6). ADDITIONAL INFORMATION: THERE IS 1 INVESTIGATION COMPLETED DURING THIS PERIOD. BREAKDOWN OF 1 COMPLETED INVESTIGATION: (B)(6) LENS DAMAGED. THE INVESTIGATION CONCLUDED, THAT PRODUCT MET MANUFACTURING RELEASE CRITERIA AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. THAT WAS RECEIVED, DURING THE TIME PERIOD THAT COVERS THIS VOLUNTARY MALFUNCTION SUMMARY REPORT HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BREAKDOWN OF 15 EVENTS IS AS FOLLOWS: COSMETIC ISSUES 1, LENS DAMAGED 14. UNIQUE IDENTIFIER (UDI#): ONLY A PORTION OF THE UDI IS PROVIDED. SERIAL NUMBER OF THE SUSPECT PRODUCT: (B)(4): 1, (B)(4): 1, (B)(4): 1, (B)(4): 1, UNKNOWN 11. REGARDING SERIAL# (B)(4), THE LENS WAS REMOVED & REPLACED AND AN INCISION ENLARGEMENT WAS DONE AS PART OF THE STANDARD TREATMENT FOR REMOVING & REPLACING THE LENS IN THE SAME PROCEDURE. 5 INVESTIGATION WERE COMPLETED, AND 0 INVESTIGATIONS ARE PENDING FROM THIS PERIOD. BREAKDOWN OF 5 COMPLETED INVESTIGATIONS: (B)(4) : LENS CUT, COSMETIC ISSUES, LENS DAMAGED, (B)(4): NO PRODUCT RETURNED, (B)(4): NO PRODUCT RETURNED, UNKNOWN: NO PRODUCT RETURNED, (B)(4): NO PRODUCT RETURNED, THE INVESTIGATION CONCLUDED THAT THE PRODUCT MET MANUFACTURING RELEASE CRITERIA. THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL, MODEL DCB00V THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL WITH TECNIS SIMPLICITY MODEL DCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 15 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155592 TECNIS OPTIBLUE SIMPLICITY PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. DCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1