BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2192710 · Received August 5, 2011

    Report

    Report Number
    2648035-2011-00154
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    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

    THE RETURNED IOL WAS MEASURED FOR DIOPTER AND WAS CORRECT AS LABELED,16.0. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RECEIVED AND IS CURRENTLY UNDER EVALUATION AT THE MANUFACTURING SITE. THE IOL MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE IMPLANT DATABASE SHOWS THE INITIAL IMPLANT OF 16.0 DIOPTER WAS REPLACED WITH A 19.5 DIOPTER LENS OF THE SAME MODEL SUGGESTING THIS EVENT WAS NOT CAUSED BY THE IOL. ALL INFORMATION AVAILABLE AT THIS TIME IS INCLUDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS WAS EXPLANTED WITHOUT COMPLICATION 1 YEAR FOLLOWING IMPLANT. THE REASON STATED WAS NOT ENOUGH POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention