BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 4267612 · Received November 20, 2014

    Report

    Report Number
    2648035-2014-00619
    Event Type
    Injury
    Date Received
    November 20, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 23, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE/ DATE OF BIRTH AND GENDER: UNKNOWN. SERIAL NUMBER: NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE (NA). LENS REMAINS IMPLANTED IN THE EYE. INITIAL REPORTER PHONE NUMBER: (B)(6). SECTION F HAS BEEN COMPLETED BY THE MANUFACTURER. DEVICE MANUFACTURE DATE: UNKNOWN AS SERIAL NUMBER WAS NOT PROVIDED. PMA/510(K) NUMBER: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL, THAT IS SIMILAR TO A PRODUCT DISTRIBUTED IN THE US, TECNIS 1-PIECE IOL ¿ PMA# P980040 ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1-2 MONTHS FOLLOWING IMPLANTATION OF INTRAOCULAR LENS (IOL), CORNEAL EDEMA WAS OBSERVED FOR 5 PATIENTS. PATIENTS WERE TREATED WITH ORAL STEROID, WHICH IMPROVED/RECOVERED THE REPORTED ISSUE. IT WAS NOTED BY THE PHYSICIAN THAT THERE WAS NO CASUAL RELATION BETWEEN THE LENS AND THIS CORNEAL EDEMA ISSUE. CAUSE OF THE REPORTED ISSUE WAS ASKED BUT UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR PATIENT #1, WHO WAS NOT FURTHER IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754911 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention