BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7546551 · Received May 25, 2018

    Report

    Report Number
    2648035-2018-00782
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    February 13, 2018
    Report Date
    May 25, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474561854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: 03/15/2018 (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS OPTIBLUE 1-PIECE IOL, MODEL PCB00V THAT HAS A SIMILAR DEVICE, TECNIS 1-PIECE IOL MODEL PCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. DEVICE RETURNED TO MANUFACTURER? YES. (B)(4). DEVICE EVALUATION: THE COMPLAINT UNIT WAS RECEIVED IN A PLASTIC BAG. PCB00V DEVICE SYSTEM WAS NOT RETURNED. ONLY THE LENS WAS RETURNED INSIDE THE OUTER POUCH OF THE DEVICE. VISUAL INSPECTION WAS PERFORMED: LUBRICANT MATERIAL AND LOOSE PARTICLES WERE OBSERVED ON THE LENS SURFACE. IT WAS OBSERVED CUT IN TWO (2) PIECES. THE CONDITION IN WHICH THE SAMPLE WAS RETURNED IS CONSISTENT WITH A PRODUCT THAT WAS PREVIOUSLY HANDLED AND PREPARED FOR SURGICAL PROCESS. DUE TO THE CONDITION IN WHICH THE SAMPLE WAS RETURNED, THE REPORTED ISSUE COULD NOT BE VERIFIED AND THE PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER AND RELATED DOCUMENT REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THERE WAS NO DISCREPANCY FOUND DURING THE REVIEW. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINT WAS RECEIVED FOR THIS PRODUCTION ORDER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT OF A MODEL PCB00V INTRAOCULAR LENS (IOL), THE PATIENT'S LENS REFRACTIVE VALUE SHIFTED TO 2.0 DIOPTER (D) MYOPIC SIDE. THE IOL WAS IMPLANTED ON (B)(6) 2018. THE REFRACTIVE SHIFT WAS DISCOVERED ON (B)(6) 2018 AND THE LENS WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2018. PATIENT''S OUTCOME IS UNKNOWN/NOT PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386542 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00V 05050474561854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention