BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 6197516 · Received December 22, 2016

    Report

    Report Number
    9614546-2016-00705
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    October 21, 2016
    Report Date
    April 23, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    UDI-DI
    05050474591820
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE 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. A SEARCH ON COMPLAINTS REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER NUMBER. 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 THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN/NOT PROVIDED. EXACT DATE WHEN PATIENT EXPERIENCED BLURRY VISION WAS NOT PROVIDED. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP IT WAS LEARNED THE PATIENT HAD COMPLAINED OF THE BLURRY VISION ON NEXT DAY, 1 WEEK, 2 WEEKS AND 1 MONTH POST-OP VISITS. IT WAS ALSO LEARNED THAT THE ZXR00 LENS WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE AND REPLACED WITH THE SAME MODEL LENS WITH A 30.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, SUTURES REQUIRED. FURTHERMORE, THE INITIAL REPORT INDICATED THAT THE EXPLANT OCCURRED ON (B)(6) 2016, HOWEVER IT WAS LEARNED THAT THIS WAS ACTUALLY THE IMPLANT DATE AND THE EXPLANT OCCURRED ON (B)(6) 2016. AGE/DATE OF BIRTH: (B)(6) 1952. GENDER/SEX: FEMALE. ON (B)(6) 2016 - AS A RESULT OF THE FOLLOW UP IT WAS LEARNED THE BLURRY VISION WAS NOTED INITIALLY THE NEXT DAY POST-OP. IF IMPLANTED, GIVE DATE: (B)(6) 2016. IF EXPLANTED, GIVE DATE: (B)(6) 2016. ADDITIONAL REPORTER: DR. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZXR00 INTRAOCULAR LENS (IOL), A PATIENT COMPLAINED ABOUT BLURRY VISION ON ALL FOUR POST-OPS. THE IOL WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848562 TECNIS SYMFONY MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXR00 05050474591820

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention