BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE 1-PIECE

    MDR report key: 4367652 · Received December 29, 2014

    Report

    Report Number
    2648035-2014-00676
    Event Type
    Injury
    Date Received
    December 29, 2014
    Report Date
    December 10, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    . PT AGE: AGE/DATE OF BIRTH: UNKNOWN. PT GENDER: SEX: UNKNOWN. DATE OF EVENT: UNKNOWN. SERIAL #: UNKNOWN. EXPIRATION DATE: UNKNOWN. IMPLANT DATE: IF IMPLANTED, GIVE DATE: UNKNOWN. EXPLANT DATE: IF EXPLANTED, GIVE DATE: UNKNOWN. INITIAL REPORTER: TELEPHONE NUMBER: (B)(6). (B)(4). PMA 510(K): THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT; TECNIS OPTIBLUE 1-PIECE IOL, MODEL ZCB00V THAT HAS A SIMILAR PRODUCT, TECNIS 1-PIECE IOL MODEL ZCB00 WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER PMA P980040. DEVICE MANUFACTURE DATE: UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S POST OP VISUAL ACUITY WAS 0.1 (20/200) AFTER IMPLANTATION OF THE MODEL ZCB00V, INTRAOCULAR LENS. THE DOCTOR ASSUMES THE POSSIBLE CAUSE OF THIS ISSUE IS THE OVER CORRECTION BY CORRECTION OF SPHERICAL ABERRATION. THE DATE OF THE EVENT IS UNKNOWN. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853574 TECNIS OPTIBLUE 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 Other