BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS TORIC IOL

    MDR report key: 2723863 · Received September 1, 2012

    Report

    Report Number
    2648035-2012-00282
    Event Type
    Injury
    Date Received
    September 1, 2012
    Report Date
    March 20, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT DATE OF IOL IS UNKNOWN. DATE OF IMPLANT IS UNK. THIS DEVICE IS NOT APPROVED BY THE FDA, HOWEVER IT IS A SAME /SIMILAR DEVICE AS MODEL ZCB00 - PMA# P990080. (B)(6). THE MANUFACTURING RECORDS SHOW THAT THIS DEVICE MET SPECIFICATIONS DURING MANUFACTURING. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS (AMO) HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND OR CONCLUSION OF THIS REPORT, ANOTHER SUPPLEMENT REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: (B)(6). DATE OF EVENT: APPROXIMATELY (B)(6) 2012, (REPORTED ONE WEEK POST-OP OF IMPLANT DATE OF (B)(6) 2012). MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN ON WHETHER THE LENS WAS EXPLANTED HAVE BEEN UNSUCCESSFUL TO DATE. IMPLANT DATE: (B)(6) 2012. (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT IS NOW HAPPY WITH THEIR VISION AND DOES NOT WANT THE DOCTOR TO REMOVE THE LENS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A POST OPERATIVE EXAM, THE PATIENT WAS EXPERIENCING REFRACTIVE SURPRISE. THE PHYSICIAN STATED HE WILL BE REMOVING THE LENS AS IT IS NOT ORIENTED CORRECTLY IN THE EYE. THE EXPLANT DATE WAS NOT MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS TORIC IOL MONOFOCAL IOL HQL ABBOTT MEDICAL OPTICS ZCT300

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention