BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 8846180 · Received July 31, 2019

    Report

    Report Number
    2648035-2019-00826
    Event Type
    Injury
    Date Received
    July 31, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. CATALOG #: UNKNOWN DUE THE FACT THAT SERIAL NUMBER IS NOT AVAILABLE. SERIAL NUMBER: UNKNOWN. EXPIRATION DATE: UNKNOWN DUE THE FACT THAT SERIAL NUMBER IS NOT AVAILABLE. UDI #: A COMPLETE UDI IS UNKNOWN AS PRODUCT LOT NUMBER WAS NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED; GIVE DATE: LENS EXPLANTED (B)(6) 2019. (B)(6). MANUFACTURE DATE: DEVICE MANUFACTURER DATE IS UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: CATALOG: 15506663, SERIAL NUMBER: (B)(4), UNIQUE IDENTIFIER (UDI): (B)(4), EXPIRATION DATE: 04/30/2008. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVALUATION, RETURNED TO MANUFACTURER ON: 8/28/2019. DEVICE EVALUATION: ON AUGUST 28, 2019 THE RETURN SAMPLE WAS RECEIVED AT MANUFACTURING SITE. THE PRODUCT WAS RECEIVED IN A LITTLE JAR WITH LIQUID. THE PRODUCT WAS DISINFECTED ACCORDING TO PROCEDURE (B)(4). THE PRODUCT WAS INSPECTED BY A QUALIFIED INSPECTOR USING A MICROSCOPE WITH A 12X MAGNIFICATION. IT WAS SEEN THAT THE LENS WAS CONTAMINATED, DUST PARTICLES WERE PRESENT. THIS WAS EXPECTED AS THE LENS WAS TRANSPORTED FROM CONTROLLED ENVIRONMENT DURING MANUFACTURING TO A NON-STERILE, NON-ENVIRONMENTAL CONTROLLED AREA. THE EDGE OF THE LENS AND THE OPTICAL BODY ARE DAMAGED. THE OPTICAL BODY SHOWED SMALL INDENTATIONS. THE COMPLAINT COULD BE CONFIRMED. INVESTIGATION OF THE RETURN SAMPLE AND THE CONDITION OF THE RETURN SAMPLE DID NOT SUGGEST THAT THE DAMAGE WAS INTRODUCED DURING MANUFACTURING. A PRODUCT OR PROCESS DEFICIENCY CANNOT BE CONFIRMED. THE REPORTED COMPLAINT WAS NOT CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) MODEL ZA90000 WAS EXPLANTED DUE TO THE LENS BECAME CLOUDY AND DISCOLORED. THE IOL WAS IMPLANTED IN YEAR 2007 AND THE INITIAL TREATMENT WAS FOR THE RIGHT EYE THAT HAD A VITRECTOMY PROCEDURE, REMOVAL OF IOL, AND INSERTION OF SCLERAL FIXATED IOL IMPLANT. THE IOL WAS EXPLANTED (B)(6) 2019. ALL INFORMATION AVAILABLE HAVE BEEN SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640649 TECNIS MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. Z9000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention