BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE 1-PIECE

    MDR report key: 10814198 · Received November 9, 2020

    Report

    Report Number
    2648035-2020-00833
    Event Type
    Injury
    Date Received
    November 9, 2020
    Date of Event
    October 12, 2020
    Report Date
    December 11, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474546844
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED, AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH IN COMPLAINT SYSTEM REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    SEX/GENDER: UNKNOWN/NOT PROVIDED. IF IMPLANTED; GIVE DATE: EXACT DATE UNKNOWN; REPORTED THAT THE LENS WAS IMPLANTED ABOUT SIX YEARS AGO. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS REMAINS IMPLANTED (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL ZCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT COMPLAINED OF BLURRY VISION ON (B)(6) 2020. THE INTRAOCULAR LENS (IOL) WAS IMPLANTED ABOUT SIX YEARS AGO. DURING A SLIT LAMP EXAMINATION, THE LOWER SIDE OF THE IOL, FROM THE FRONT OF THE PATIENT, INSIDE OF THE IOL HAD BECOME CLOUDY, SNOW-LIKE SUBSTANCES WERE SPREAD WHICH LOOKED LIKE WHITENING. THESE COULD BE OBSERVED BY LOOKING UNDER A SLIT WITH THE NAKED EYE, BUT THEY COULD NOT BE SEEN IN A SLIT PHOTO. ALSO, THE CLOUDY CONDITION COULD NOT BE REFLECTED IN THE FUNDUS PHOTOGRAPH. IN THE FUNDUS PHOTOGRAPH, IT SEEMED AS IF IT WAS LIGHT CLOUD, AND IT WAS OBSERVED THAT BLOOD VESSELS WERE NOT EASY TO BE SEEN. THE VISUAL ACUITY WAS 1.2. REPORTEDLY, THE HAZE OBSERVED THIS TIME HAD INCREASED FROM THAT OF THE LAST TIME WHEN THE PHOTO OF OCULAR FUNDUS WAS TAKEN AT THE REGULAR CHECKUP IN (B)(6) OF 2020. THE PATIENT IS UNDER OBSERVATION AND IF BLURRY VISION CONTINUES, REMOVAL OF THE LENS WILL BE CONSIDERED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277524 TECNIS OPTIBLUE 1-PIECE MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. ZCB00V 05050474546844

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other