BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE

    MDR report key: 7449654 · Received April 21, 2018

    Report

    Report Number
    2648035-2018-00571
    Event Type
    Malfunction
    Date Received
    April 21, 2018
    Date of Event
    March 22, 2018
    Report Date
    May 19, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531758
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SHIPMENT OF THE LENS FRAGMENT WAS RECEIVED AT (B)(4), BUT COULD NOT BE LOCATED DUE TO CONTENTS SHIFTING DURING TRANSIT. THEREFORE, THE COMPLAINT REPORTED COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED EITHER. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO THE SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL PIECE OF LENS FRAGMENT WAS SITTING ON TOP OF THE OPTIC OF A ZCB00 22.0 DIOPTER LENS AFTER BEING IMPLANTED IN THE PATIENT'S OPERATIVE EYE. THE FRAGMENT WAS EASILY REMOVED FROM THE EYE USING FORCEPS AND THERE WAS NO VISIBLE DAMAGE TO ANY PART OF THE LENS. THE LENS REMAINS IMPLANTED. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THERE WAS NO PATIENT INJURY AND THE PATIENT HAD A GOOD OUTCOME WITH NO ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292311 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531758

    Patients

    Seq Age Sex Outcome Treatment
    1