BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 6695821 · Received July 8, 2017

    Report

    Report Number
    2648035-2017-01228
    Event Type
    Injury
    Date Received
    July 8, 2017
    Date of Event
    June 5, 2017
    Report Date
    September 4, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474528932
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: IN THE INITIAL MDR, IF EXPLANTED; GIVE DATE WAS ENTERED IN ERROR. THE EXPLANT DATE OF THE DEVICE WAS CORRECTLY ENTERED IN THE REPORT, (B)(6) 2017. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: UPON FURTHER REVIEW IT WAS OBSERVED THAT AN INCORRECT PMA# WAS PROVIDED IN THE INITIAL MDR. THE CORRECT PMA# FOR THIS DEVICE IS P990080. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVALUATION ¿ YES, RETURNED TO MANUFACTURER ON 07/19/2017. DEVICE RETURNED TO MANUFACTURER ¿ YES. DEVICE EVALUATION: THE ZA9003 LENS RETURNED IN A BAG. VISUAL INSPECTION WAS PERFORMED AT 10X MICROSCOPE MAGNIFICATION:THE LENS WAS RECEIVED CUT IN TWO PIECES TYPICALLY OF A REMOVED LENS. THE HAPTICS WERE OBSERVED POSITIONED AND WITHOUT DEFECTS. SINCE NO A SPECIFIC DETAIL ABOUT THE COMPLAINT WITH THE LENS WAS PROVIDED THE COMPLAINT CANNOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH ON COMPLAINTS REVEALED THAT NO OTHER COMPLAINT HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW UP IT WAS LEARNED THAT THERE WAS NOTHING WRONG WITH THE LENS ITSELF. THE PATIENT WAS UNHAPPY WITH HER VISION AND REQUIRED A DIOPTER SIZE CHANGE. THE LENS WAS ORIGINALLY IMPLANTED ON (B)(6) 2017 AND EXPLANTED ON (B)(6) 2017 FROM THE LEFT EYE. THERE WAS NO INCISION ENLARGEMENT, HOWEVER A SUTURES WAS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. AGE/DATE OF BIRTH: (B)(6). GENDER/SEX: FEMALE. IF IMPLANTED, GIVE DATE: (B)(6) 2017. IF EXPLANTED, GIVE DATE: (B)(6) 2017. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MODEL ZA9003 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED AS THE LENS DID NOT MEET THE PATIENT'S EXPECTATIONS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476711 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003 05050474528932

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention