BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2519246 · Received April 5, 2012

    Report

    Report Number
    9614546-2012-00050
    Event Type
    Injury
    Date Received
    April 5, 2012
    Date of Event
    February 27, 2012
    Report Date
    March 12, 2012
    Manufacturer
    AMO PUERTO RICO, INC.
    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

    EVALUATION OF THE RETURNED LENS FOUND IT BE COVERED WITH SURFACE RESIDUE, NOT INCONSISTENT WITH AN EXPLANTED LENS. NO DEFECTS WERE OBSERVED WITH THE LENS OPTIC BODY AND HAPTICS OF THE LENS. DIOPTER INSPECTION OF THIS LENS FOUND IT TO MEET SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE INTRAOCULAR LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: MFR REPORT # SHOULD HAVE BEEN (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4) INTRAOCULAR LENS (IOL) EXPLANT. THE LENS HAS BEEN RECEIVED FOR RETURN AT THE ABBOTT MEDICAL OPTICS (AMO) IN (B)(4) AND HAS BEEN SHIPPED TO THE AMO MANUFACTURING FACILITY IN (B)(4). THE EVALUATION IS PENDING. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DUE TO THE INCORRECT IOL (INTRAOCULAR LENS) POWER CHOICE, THE IOL WAS EXPLANTED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL IOLS HQL AMO PUERTO RICO, INC. ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention