BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 5895201 · Received August 22, 2016

    Report

    Report Number
    9614546-2016-00404
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    June 28, 2016
    Report Date
    September 26, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474574328
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INITIAL MDR, THE PRODUCT CODE WAS INCORRECTLY PROVIDED AS MFK. PRODUCT CODE: POE (CORRECTED). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LENS WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED, THEREFORE THE REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS WERE REVIEWED AND THE LENS WAS MANUFACTURED ACCORDING TO SPECIFICATION. THERE WERE NO NON-CONFORMANCES WITH RESPECT TO THE MANUFACTURING PROCESS. THERE WERE NO ASSOCIATED NONCONFORMITY REPORTS OR DEVIATIONS. THE IN-LINE OPTICAL INSPECTION DATA SHOWS THE LENS IS WITHIN OPTICAL AND CYLINDER POWER SPECIFICATION; HENCE THE LENS MEETS THE SPECIFIED COSMETIC REQUIREMENTS. A SEARCH ON COMPLAINTS REVEALED THAT NO OTHER COMPLAINTS FOR THIS ORDER NUMBER WERE RECEIVED TO DATE. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE INTRAOCULAR LENSES. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN, NOT PROVIDED. GENDER/SEX: UNKNOWN, NOT PROVIDED. EXPLANT DATE: IF EXPLANTED; GIVE DATE: NA (NOT APPLICABLE) TO DATE, THE INTRAOCULAR LENS REMAINS IMPLANTED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYMFONY LENS WAS IMPLANTED AND WITHIN THE 2 WEEKS POST OPERATIVE TIME FRAME, THE LENS HAD ROTATED. THE LENS WAS REPOSITIONED IN A SECONDARY PROCEDURE. THE DEGREE OF ROTATION WAS NOT PROVIDED. THE REPOSITION WENT VERY WELL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544604 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXT150 05050474574328

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention