BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 4600327 · Received March 13, 2015

    Report

    Report Number
    2648035-2015-00129
    Event Type
    Injury
    Date Received
    March 13, 2015
    Report Date
    February 19, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN. GENDER/SEX: UNKNOWN. DATE OF EVENT: UNKNOWN. SERIAL NUMBER: UNKNOWN, EXPIRATION DATE: UNKNOWN. IMPLANT DATE: IF IMPLANTED, GIVE DATE: UNKNOWN. EXPLANT DATE: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, (NA) TO DATE THE INTRAOCULAR LENS REMAINS IMPLANTED. INITIAL REPORTER: TELEPHONE NUMBER: (B)(6). PMA 510(K): THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT; TECNIS ITEC PRELOADED 1-PIECE IOL, MODEL PCB00 THAT HAS A SIMILAR PRODUCT, TECNIS 1-PIECE IOL, MODEL ZMB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. REASON FOR NON EVALUATION: TO DATE, THE INTRAOCULAR LENS REMAINS IMPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED A TEAR IN THE CAPSULE BAG WHEN THE HAPTIC CAME FROM BEHIND THE LENS. THERE WAS NO MAJOR COMPLICATION AFTERWARD. THE LENS REMAINS IMPLANTED AND THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175794 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other