BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 8525230 · Received April 17, 2019

    Report

    Report Number
    2648035-2019-00470
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    March 18, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531529
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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

    ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVALUATION; RETURNED TO MANUFACTURER ON: 4/30/2019. DEVICE EVALUATION: THE LENS WAS EVALUATED, THERE WAS A DEPRESSION MARK (SEVERAL CUTS), AND FIBERS/PARTICLES WERE OBSERVED ON LENS SURFACE, RELATING TO THE HANDLING OF THE UNIT OUT OF NON-STERILE ENVIRONMENT. RESIDUES OF VISCOELASTIC SOLUTION WERE ALSO OBSERVED ON LENS WHICH INDICATED THAT THE UNIT WAS HANDLED AND PREPARED FOR SURGICAL USE. THERE WAS NO ISSUE REPORTED AGAINST THE LENS. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. THE SEARCH REVEALED THAT NO SIMILAR COMPLAINT FOR THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. 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

    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. (B)(4). AN ATTEMPT WAS MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO FURTHER INFORMATION COULD BE PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CHANGE IN PATIENT ANATOMY AND THERE WAS NO ISSUE WITH THE LENS. HOWEVER, A VITRECTOMY WAS REQUIRED. IT IS UNKNOWN IF THE VITRECTOMY OCCURRED PRIOR TO PATIENT CONTACT OR DURING PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318745 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531529

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention