BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 8666829 · Received June 4, 2019

    Report

    Report Number
    2648035-2019-00617
    Event Type
    Injury
    Date Received
    June 4, 2019
    Report Date
    November 12, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474561809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION; RETURNED TO MANUFACTURER ON: 06/05/2019. DEVICE EVALUATION: THE PCB00V LENS WAS RECEIVED INSIDE A BOX. THE LENS WAS OBSERVED CUT. THE CONDITION OBSERVED IS CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED. THE SAMPLE WAS EVALUATED AND RESIDUES OF VISCOELASTIC WAS OBSERVED, NOTHING OUT OF SPECIFICATION WAS OBSERVED ON THE EDGES OF THE LENS AND THE HAPTICS. THE REPORTED ISSUE WAS NOT VERIFIED AND IT COULD NOT BE DETERMINED IF THE CONDITION OBSERVED IS RELATED TO MANUFACTURING PROCESS AS THE REPORTED LENS WAS USED AND CUT IN A SURGICAL PROCEDURE. BASED ON THE PRODUCT RETURNED EVALUATION, A PRODUCT QUALITY DEFICIENCY OR PRODUCT MALFUNCTION COULD NOT BE DETERMINED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORD REVIEW WAS PERFORMED, AND THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH IN COMPLAINT HISTORY REVEALED NO OTHER COMPLAINT WAS RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. 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 · 1

    IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. (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. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAPTIC CAME IN CONTACT WITH THE POSTERIOR CAPSULE DURING THE IMPLANT, AND A TEAR OCCURRED. THE LENS WAS REMOVED AND A THREE-PIECE LENS WAS IMPLANTED. THE DOCTOR COMMENTED THAT THE LENS WAS NOT POLISHED ENOUGH AND THAT A TEAR WAS INTRODUCED. ADDITIONAL FOLLOW-UP STATES DOCTOR PERFORMED A-VIT TREATMENT AND ENLARGED THE INCISION TO REMOVE LENS OUTSIDE THE EYE. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461878 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00V 05050474561809

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention