BEUDAMED
    FDA Adverse Event Death Summary report: N

    TECNIS

    MDR report key: 8406241 · Received March 8, 2019

    Report

    Report Number
    2648035-2019-00304
    Event Type
    Death
    Date Received
    March 8, 2019
    Report Date
    November 9, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474529052
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: FURTHER INFORMATION WAS PROVIDED AND REPORTED LENS WAS DAMAGED (HAPTIC BENT) DURING LOADING. THIS COMPLAINT IS NO LONGER CONSIDERED A REPORTABLE MALFUNCTION. NO FURTHER INFORMATION WILL BE PROVIDED UNDER THIS MANUFACTURER REPORT NUMBER 2648035-2019-00304.. ADDITIONAL INFORMATION DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 3/15/2019. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: LUBRICANT MATERIAL RESIDUE AND LOOSE PARTICLES CAN BE OBSERVED ON THE LENS SURFACE THAT COULD BE RELATED TO HANDLING THE PRODUCT IN NON-STERILE ENVIRONMENT. THE HAPTICS LOOK SLIGHTLY DISTORTED. THE REPORTED ISSUE OF HAPTIC DAMAGED WAS VERIFIED. HOWEVER, THE CONDITION IN WHICH THE RETURNED LENS WAS RECEIVED INDICATED THAT THE UNIT WAS PREVIOUSLY HANDLED. IT WAS NOT POSSIBLE TO DETERMINE THAT THE REPORTED ISSUE IS RELATED TO THE MANUFACTURING PROCESS. BASED ON THE ANALYSIS, A PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. A SEARCH OF COMPLAINT REVEALED ONE OTHER COMPLAINT WAS RECEIVED UNDER THIS PRODUCTION ORDER; HOWEVER, IT WAS NOT CONFIRMED AS A MANUFACTURING ERROR, AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. 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 PRODUCT. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    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: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED; THEREFORE, IT WAS NOT EXPLANTED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) LENS HAD A BENT HAPTIC. THERE WAS NO PATIENT CONTACT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199274 TECNIS MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZA9003 05050474529052

    Patients

    Seq Age Sex Outcome Treatment
    1