BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 12369150 · Received August 26, 2021

    Report

    Report Number
    2020664-2021-07155
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    January 26, 2021
    Report Date
    October 19, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474531710
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION. A CUSTOMER PROVIDED PHOTO WAS RECEIVED FOR EVALUATION WHICH WAS FORWARDED TO THE RAPID RESPONSE TEAM (RRT) FOR FURTHER EVALUATION. PER SUBJECT MATTER EXPERT (SME) FROM THE RRT, THE PHOTO EVALUATION IS AS FOLLOWS. THE 2 PROVIDED PICTURES SHOW SLIT LAMP PICTURES TAKEN USING RETROILUMINATION AND DARK FIELD TECHNIQUE PSEUDOPHACKIC EYE SHOWING AN INTRAOCULAR LENS LUXATED DOWNWARDS, LIKE SUN SET SYNDROME AND A POSTERIOR CAPSULE INTEGRITY COMPROMISED STARTING RIGHT AT THE SUPERIOR EDGE OF THE IOL OPTICAL PORTION, ALTHOUGH IT IS POSSIBLE THAT THE IOL LUXATION WAS TRIGGERED BY THE POSTERIOR CAPSULE RUPTURE, IT CAN NOT BE CONFIRMED FROM THE PICTURE ASSESSMENT. NO ISSUES WITH THE DEVICE WERE OBSERVED, THE OBSERVED PHENOMENON IN THE CUSTOMER PROVIDED PHOTO IS RELATED TO PATIENT/ANATOMICAL ISSUES. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THE SEARCH REVEALED NO ADDITIONAL COMPLAINTS FROM THIS PRODUCTION ORDER NUMBER HAS BEEN RECEIVED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    WEIGHT: UNKNOWN, INFORMATION NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS THE LENS WAS DISCARDED. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. (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 A ZCB00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO LENS GETTING DISLOCATED. ALSO PPV AND LIMBAL RELAXATION INCISIONS WERE DONE AT THE TIME OF EXPLANT. PATIENT WAS REFERRED ON DAY 1 POST OP FOR A DISLOCATED IOL THROUGH THE POSTERIOR CAPSULE DURING SURGERY AND DOCTOR'S REPORT STATES THAT ANTERIOR CAPSULE APPEARS TO BE INTACT, LENS DISLOCATED BEHIND THE POSTERIOR CAPSULE IN ANTERIOR VITREOUS, POSTERIOR CAPSULE WAS DISRUPTED. ADDITIONAL DETAILS RECEIVED STATES THAT DISLOCATION HAPPENED AT THE TIME OF SURGERY. THERE WAS NO PATIENT INJURY. INCISION WAS NOT ENLARGED TO REMOVE THE LENS FROM PATIENT'S EYE AND ALSO NO SUTURES WERE DONE. THE REPLACEMENT LENS USED IS A DIFFERENT MODEL (ZA9003), ZA9003 SAME DIOPTER LENS. PATIENT OUTCOME WAS GOOD AND NO PATIENT INJURY WAS REPORTED. SUSPECT PRODUCT HAS BEEN DISCARDED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267408 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00 05050474531710

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention