BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7508558 · Received May 11, 2018

    Report

    Report Number
    2648035-2018-00693
    Event Type
    Injury
    Date Received
    May 11, 2018
    Date of Event
    April 12, 2018
    Report Date
    May 11, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC
    Product Code
    HQL
    UDI-DI
    05050474561779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN, NOT PROVIDED. SEX/GENDER: UNKNOWN, NOT PROVIDED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL, MODEL PCB00V THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL PCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. (B)(4). DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) 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 RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. 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, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL PCB00V +20.5 DIOPTER) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. AFTER THE SURGERY, THE PATIENT LEFT THE OPERATING ROOM. IT WAS WHILE PREPARING FOR THE NEXT PATIENT THAT THE THEATER STAFF REALIZED THAT THE LENS PCB00V +20.5 WAS NOT INTENDED TO BE IMPLANTED IN THAT PATIENT. REPORTEDLY, THE PATIENT IDENTITY VERIFICATION WAS NOT DONE. THE PATIENT, THEN IN THE WAITING ROOM CAME BACK. THERE WAS A DELAY OF 15 TO 20 MINUTES BEFORE THE LENS WAS EXPLANTED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349276 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC PCB00V 05050474561779

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention