BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 7856188 · Received September 7, 2018

    Report

    Report Number
    2648035-2018-01222
    Event Type
    Injury
    Date Received
    September 7, 2018
    Date of Event
    July 26, 2018
    Report Date
    November 3, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474530768
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION 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

    IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN THE INITIAL MDR 2648035-2018-01222 THE PRODUCT CODE WAS INCORRECTLY ENTERED AS HNO. THE CORRECT CODE IS HQL. (B)(4). ADDITIONAL INFO: DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 09/28/2018. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER THE MICROSCOPE SHOWED LOOSE PARTICLES AND LUBRICANT MATERIAL RESIDUE ON THE LENS SURFACE. THE HAPTICS WERE DISTORTED, WHICH COULD BE RELATED TO THE HANDLING OF THE LENS DURING THE REMOVAL PROCESS. THE CUSTOMER'S REPORTED COMPLAINT WAS VERIFIED, HOWEVER, THERE WAS NO INDICATION OF PRODUCT QUALITY DEFICIENCY. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WAS REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: IN THE SUPPLEMENTAL MDR 2648035-2018-01222, THE CONCLUSION CODE WAS INADVERTENTLY NOT POPULATED. THE FIELD WAS UPDATED ACCORDINGLY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS CONCERNED OF Z9002 MONOFOCAL INTRAOCULAR LENS (IOL) WOULD NOT CENTER IN THE RIGHT EYE (OD) DUE TO PATIENT'S ANATOMY. THE DOCTOR OPTED TO REMOVE AND REPLACE WITH NON-JNJSV (JOHNSON & JOHNSON SURGICAL VISION) PRODUCT. IT WAS NOTED THAT INCISION ENLARGEMENT WAS PERFORMED TO REMOVE THE LENS. HOWEVER, THERE WAS NO PATIENT INJURY AS THE PATIENT IS DOING FINE POST-SURGERY. PRODUCT IS EXPECTED TO BE RETURNED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698955 TECNIS CL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. Z9002 05050474530768

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention