BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8563522 · Received April 30, 2019

    Report

    Report Number
    2648035-2019-00508
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Report Date
    October 28, 2020
    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

    TYPOGRAPHICAL ERROR. IN THE INITIAL REPORT IT WAS SAID 2 INVESTIGATIONS WERE COMPLETED - THE RIGHT NUMBER IS 3. IN ADDITION IT WAS REPORTED THAT SERIAL NUMBER (B)(4) WAS INCORRECT. THE CORRECT SN IS (B)(4). 16 INVESTIGATIONS WERE COMPLETED FOR THE PERIOD. IN 12 THE PRODUCT WAS RETURNED AND IN 4 THE PRODUCT WAS NOT RETURNED. THE INVESTIGATIONS CONCLUDED THERE WAS NO MANUFACTURING 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 AND G. 4 DATE 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 · 0

    2 INVESTIGATIONS WERE COMPLETED FROM THE PERIOD AND BREAKDOWN IS AS FOLLOWS: 1 LENS CUT,HAPTIC DETACHED, 1 STUCK IN CARTRIDGE. 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

    BREAKDOWN OF THE (B)(4) EVENTS OF LENS DAMAGE IS AS FOLLOWS: (B)(4) EVENTS WERE FOR HAPTIC DAMAGE. (B)(4) EVENTS WERE FOR LENS DAMAGED. (B)(4) EVENTS WERE FOR HAPTIC DETACHED. (B)(4) EVENT WAS FOR IMPROPERLY LOADED, LENS DAMAGED. (B)(4) EVENT WAS FOR COSMETIC, LENS DAMAGED. (B)(4) EVENTS WERE FOR COSMETIC ISSUES. (B)(4) EVENT WAS FOR COSMETIC, DIFFICULT TO USE, HANDLING PROBLEM. (B)(4) EVENS WERE FOR DEFECTIVE. OUT OF (B)(4) EVENTS (B)(4) REPORTED THERE WAS REMOVAL AND REPLACEMENT. PRODUCTS HAVE NOT BEEN RETURNED. SERIAL NUMBERS OF SUSPECT PRODUCTS. (B)(4). TWO INVESTIGATIONS WERE COMPLETED. FOR BOTH THE SUSPECT PRODUCT WAS NOT RETURNED, THE INVESTIGATIONS CONCLUDED THE PRODUCTS 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.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 22 </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
    357497 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1