BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3051630 · Received April 10, 2013

    Report

    Report Number
    2648035-2013-00165
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    November 1, 2012
    Report Date
    March 19, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER. THE LENS WAS INSPECTED UNDER MICROSCOPE AT 10X AND IT WAS FOUND TO HAVE STAINS AND PARTICLES ADHERED TO BOTH SIDES OF OPTIC BODY COMPATIBLE WITH HANDLING LENS IN AN UNSTERILE ENVIRONMENT. DIOPTER VERIFICATION: DIOPTER MEASUREMENT RESULTS SHOWED THAT THE LENS FOR SERIAL NUMBER (B)(4) BELONGS TO DIOPTER 22.5. THE PRODUCT MET THE ACCEPTANCE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER. THE LENS WAS INSPECTED UNDER MICROSCOPE AT 10X AND IT WAS FOUND TO HAVE STAINS AND PARTICLES ADHERED TO BOTH SIDES OF OPTIC BODY COMPATIBLE WITH HANDLING LENS IN AN UNSTERILE ENVIRONMENT. DIOPTER VERIFICATION: DIOPTER MEASUREMENT RESULTS SHOWED THAT THE LENS FOR SERIAL NUMBER (B)(4) BELONGS TO DIOPTER 22.5. THE PRODUCT MET THE ACCEPTANCE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRAOCULAR LENS IN THE RIGHT EYE WAS EXPLANTED AND ANOTHER LENS IMPLANTED BECAUSE THE SURGEON FELT THAT THERE WOULD BE A BETTER OUTCOME WITH A DIFFERENT LENS POWER. RESULT OF NEW IMPLANT WAS GOOD; NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149517 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention