BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 11009061 · Received December 15, 2020

    Report

    Report Number
    2648035-2020-00933
    Event Type
    Injury
    Date Received
    December 15, 2020
    Report Date
    March 17, 2021
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474528932
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D10: RETURNED TO MANUFACTURER ON: 1/6/2021. SECTION H3: DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED IN THE REPLACEMENT LENS (ALCON) CASE. AN ALCON FOLDING CARTON WITH CUSTOMER NOTES, A COMPLETED JJSV SHIPPING GUIDE, AND ADDITIONAL DOCUMENTATION WERE RECEIVED AS WELL. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED, VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTICS. AND THAT THE LENS WAS RETURNED CUT IN HALF. WHICH IS CONSISTENT WITH A LENS, THAT WAS HANDLED DURING EXPLANT. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED. AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THE SEARCH REVEALED, ONE COMPLAINT FROM THIS PRODUCTION ORDER NUMBER. HOWEVER, THE REPORTED ISSUE IS UNRELATED TO THIS REPORTED COMPLAINT. AND NO PRODUCT DEFICIENCY WAS IDENTIFIED IN THAT CASE. 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT RIGHT EYE DUE TO PATIENT DESIRED DIFFERENT REFRACTIVE OUTCOME. THERE WAS NO ADDITIONAL SURGICAL/MEDICAL INTERVENTION REQUIRED. THE LENS WAS REPLACED BY TFAT00 16.5 DIOPTER LENS. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480302 TECNIS MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZA9003 05050474528932

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention