BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHACOFLEX II

    MDR report key: 8862926 · Received August 6, 2019

    Report

    Report Number
    2648035-2019-00846
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Report Date
    November 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE LENS ASSOCIATED TO THE COMPLAINT REMAINS IMPLANTED. THEREFORE, A PRODUCT EVALUATION IS NOT POSSIBLE. THE REPORTED ISSUE COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THE SEARCH REVEALED NO ADDITIONAL INVESTIGATION REQUEST ASSOCIATED TO THE MANUFACTURING DATE AND/OR 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.

    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-010215.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. GENDER/SEX: UNKNOWN, INFORMATION NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, REMAINS IMPLANTED IN THE EYE. INITIAL REPORTER NAME, PHONE NUMBER, AND FULL ADDRESS: UNKNOWN, INFORMATION NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON NOTICED PATIENT INTRAOCULAR LENS(IOL) HAD OPACIFICATION. REPORTEDLY VISUAL ACUITY IS 20/40 BUT IF VISION WORSENS THERE WILL BE PLANNED EXPLANT. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661047 PHACOFLEX II MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. SI30NB

    Patients

    Seq Age Sex Outcome Treatment
    1