BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 5240628 · Received November 20, 2015

    Report

    Report Number
    2648035-2015-01182
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    December 17, 2015
    Report Date
    January 19, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PATIENT UNHAPPY, PLANNED EXPLANT OF THE LENS. MANUFACTURE DATE: UNKNOWN.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED. DIAGNOSIS: GLARE/UNCLEAR VISION ANY DISTANCE. LENS WAS REPLACED WITH A NON AMO LENS, A 15.5 DIOPTER LENS. OUTCOME WAS REPORTED THAT 1 DAY AFTER, VISUAL ACUITY WAS 20/30. PATIENT NOT HAPPY YET. TO REMOVE THE LENS, A NEW INCISION WAS MADE, 4MM (ORIGINAL WAS 2.75MM). NO VITREOUS WAS ENCOUNTERED. CAPSULAR BAG REMAINED INTACT AND IOL WAS PLACED IN BAG ON CORRECTIVE TORIC AXIS. UDI #: (B)(4). PT AGE/DATE OF BIRTH: (B)(6) 1947 WAS PROVIDED. THE BEST ESTIMATE DATE HAS BEEN ENTERED AS (B)(6) 1947. PT GENDER/SEX: MALE. OUTCOME ATTRIBUTED TO ADVERSE EVENT HAS BEEN UPDATED TO: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES) MODEL: ZLB00, SERIAL NUMBER: (B)(4), CATALOG #: ZLB00U0150, EXPIRATION DATE: 02/25/2019. IMPLANT DATE: IF IMPLANTED; GIVE DATE: (B)(6) 2015. EXPLANT DATE: IF EXPLANTED; GIVE DATE: (B)(6) 2015. (B)(4). PMA/510(K): P980040. DEVICE MANUFACTURE DATE: 02/25/2015. THE ORIGINAL MDR REFERENCES A MANUFACTURING SITE OF (B)(4) AND MANUFACTURING SITE REPORT NUMBER AS (B)(4). AS THE SERIAL NUMBER IS NOW KNOWN, THE MANUFACTURE SITE HAS BEEN UPDATED: MFG SITE: (B)(4) ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WOULD BE EXPLANTED AS THE PATIENT WAS VERY UNHAPPY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768723 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZLB00

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R