BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 2834475 · Received November 15, 2012

    Report

    Report Number
    2648035-2012-00360
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION STATED THAT THE ABBOTT MEDICAL OPTICS INTRAOCULAR LENS (IOLS) ARE NOT SUSPICIOUS ANYMORE, BECAUSE IT HAPPENED ALSO WITH OTHER TYPES OF IOLS. TO DATE, THE LENS REMAINS IMPLANTED. THE MANUFACTURING RECORD REVIEW INDICATED THAT ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORDS FROM GENERATION TO BOXING WERE IN COMPLIANCE. THE DOCUMENTATION SHOWS THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    PATIENT OUTCOME: NO VISIBLE DAMAGE, VISUAL ACUITY 0.8. IN THE PATIENT'S ANTERIOR CHAMBER, CORPUS VITREUM AND CONJUNCTIVA AND GENERAL BLOOD INVESTIGATION (B)(6) WAS FOUND. THE PATIENT WAS TREATED WITH TOPICAL CHLORAMPHENICOL AND MOXIFLOXACIN ORALLY. THE HOSPITAL WAS AUDITED BY THE HYGIENE EXPERTS (MICROBIOLOGIST, STERILIZATION EXPERT, HOSPITAL HYGIENIST) FROM THE UNIVERSITY HOSPITAL AND MAY TESTS WERE PERFORMED. THE BALANCED SALT SOLUTION WAS NOT TESTED. THERE WAS NO LINK TO ANYTHING AT ALL THAT WAS USED IN THE OPERATING ROOM (OR) OR THAT COULD HAVE CAUSED THE INFECTIONS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE DOCTOR STATING THAT THE COMPLAINT WAS NOT RELATED TO THE ABBOTT MEDICAL OPTICS PRODUCT. IT WAS STATED THAT THE DOCTOR FOUND DIFFERENT TYPES OF BACTERIA THAT WERE RELATED TO THE PATIENT AND NOT TO THE INTRAOCULAR LENS. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ABBOTT MEDICAL OPTICS IN EUROPE REPORTED THAT A PATIENT EXPERIENCED ENDOPHTHALMITIS AFTER IMPLANTATION OF AN INTRAOCULAR LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ENDOLSOL BALANCED SALT SOLUTION