BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 10075069 · Received May 20, 2020

    Report

    Report Number
    2648035-2020-00419
    Event Type
    Injury
    Date Received
    May 20, 2020
    Report Date
    October 30, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474529069
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 (B)(4) AND CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS DURING (B)(6) 2020. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVALUATION, RETURNED TO MANUFACTURER ON 5/14/2020. DEVICE EVALUATION: THE SAMPLE WAS EVALUATED, AND THE LENS WAS OBSERVED CUT WITH RESIDUES OF VISCOELASTIC RELATED TO THE HANDLING OF THE UNIT IN A SURGICAL PROCEDURE. THE CONDITION OBSERVED IS CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED. THE REPORTED ISSUE WAS NOT VERIFIED AND IT COULD NOT BE DETERMINED IF THE CONDITION OBSERVED IS RELATED TO MANUFACTURING PROCESS SINCE IMPACTED LENS WAS USED AND CUT IN A SURGICAL PROCEDURE. BASED ON THE PRODUCT RETURNED EVALUATION, A PRODUCT QUALITY DEFICIENCY OR PRODUCT MALFUNCTION COULD NOT BE DETERMINED. THE MANUFACTURING PO WERE EVALUATED, AND THE LENS WERE MANUFACTURED WITHIN SPECIFICATIONS. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO OTHER COMPLAINT FOLDER HAS BEEN CREATED FOR THIS PRODUCTION ORDER NUMBER. 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 THE LENS WAS EXPLANTED DUE TO PATIENT BEING UNHAPPY WITH DISTANCE ACUITY IN THE LEFT EYE. THERE WAS NO PATIENT INJURY OR ANY OTHER MEDICAL OR SURGICAL INTERVENTION. THE ORIGINAL INCISION WAS RE-OPENED, NO ENLARGEMENT OF INCISION WAS PERFORMED. REPLACEMENT LENS OF SAME MODEL WAS USED ZA9003 21.0D SN # (B)(4). PATIENT IS OK SO FAR POST-OP. PRE-EXCHANGE TRIED COMPACT LENS BUT EYE WAS TOO DRY TO BE COMFORTABLE. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537855 TECNIS MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZA9003 05050474529069

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention