BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2439146 · Received January 31, 2012

    Report

    Report Number
    2648035-2012-00008
    Event Type
    Injury
    Date Received
    January 31, 2012
    Report Date
    January 3, 2012
    Manufacturer
    A.M.O. PUERTO RICO, INC.
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER AMO'S IMPLANT REGISTRY DATA BASE, (B)(4) IS FOR THE PATIENT'S RIGHT EYE. THE PATIENT PROVIDED THAT HER DOCTOR'S NAME IS DR (B)(6). (B)(6). TO THE BEST OF OUR KNOWLEDGE, THE LENSES HAVE NOT BEEN EXPLANTED. 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. THE MEDWATCH SUBMITTED FOR THE PATIENT'S LEFT EYE IS 2648035-2012-00009.

    Description of Event or Problem · 1

    A PATIENT FILED A COMPLAINT VIA THE ABBOTT MEDICAL OPTICS (AMO) HOMEPAGE STATING THAT SHE WAS A (B)(6) POST LASIK PATIENT (15 YEARS AGO) WHO HAD CATARACTS REMOVED FROM BOTH EYES FIVE MONTHS AGO. SHE HAD A MONOFOCAL TECNIS LENS INSERTED IN EACH EYE. THE PATIENT WANTED MULTI-FOCAL AND WAS TOLD THIS WAS NOT THE BEST OPTION. THE PATIENT STATED THAT SHE HAS NO FUNCTIONAL VISION AND STATED THAT HER VISION WAS BETTER WITH HER CATARACTS AND WAS SORRY SHE LET THE SURGEON IMPLANT THE LENSES. SHE PLANS ON REMOVING. IN ADDITION, THE PATIENT SAID THAT HER SURGEON SAYS 'SOMETHING IS WRONG, BUT HE DOES NOT KNOW WHAT AND CAN'T FIX IT OR EVEN CORRECT VISION WITH CONTACTS'. THE PATIENT STATED THAT SHE HAS ALREADY SEEN MULTIPLE VISION EXPERTS AND NOW NEEDS TO CONSIDER MEDICAL DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS CL HQL: MONOFOCAL IOLS HQL A.M.O. PUERTO RICO, INC. Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other