BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 14628575 · Received June 7, 2022

    Report

    Report Number
    3012236936-2022-01458
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 13, 2022
    Report Date
    June 27, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474561793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANT DATE: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, LENS REMAINS IMPLANTED IN THE EYE. TELEPHONE NUMBER: (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. THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS THE LENS REMAIN IMPLANTED IN THE EYE. 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. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO DEFINITIVE RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED AND THE FOLLOWING FIELDS WERE UPDATED ACCORDINGLY: SECTION B3 - DATE OF EVENT: MAY 13, 2022. SECTION D6A: IMPLANT DATE: (B)(6) 2022. SECTION E1: INITIAL REPORTER'S TITLE, FIRST & LAST NAME: DR. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRAILING HAPTIC OF THE PRELOADED INTRAOCULAR LENS (IOL) WAS NOT FOLDED NORMALLY. THE HAPTIC HAD BENT OUTWARD IN THE CARTRIDGE. THE LENS WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY AND THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2413240 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. PCB00V 05050474561793

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown