BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 10549127 · Received September 17, 2020

    Report

    Report Number
    2648035-2020-00694
    Event Type
    Injury
    Date Received
    September 17, 2020
    Report Date
    November 26, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474531604
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION WAS PROVIDED AND REPORTED THE PATIENT¿S SYMPTOMS FIRST NOTED IMMEDIATELY AFTER SURGERY IN THE LEFT EYE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND HIGHER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT WAS DOING EXCELLENT AT THE TIME OF DISCHARGE. NO ADDITIONAL INFORMATION WAS PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN/NOT PROVIDED. IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. (B)(4). DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE, PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER¿S REPORTED COMPLAINT COULD NOT BE VERIFIED. 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. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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 THE PATIENT HAD A REFRACTIVE SURPRISE NEAR A -2.0D WITH AN INTRAOCULAR LENS (IOL). THROUGH FOLLOW-UP, IT WAS CONFIRMED THE LENS WAS EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009824 TECNIS 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00 05050474531604

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention