BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 2836524 · Received November 16, 2012

    Report

    Report Number
    2648035-2012-00362
    Event Type
    Injury
    Date Received
    November 16, 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

    PATIENT OUTCOME GIVEN AS STRONG VISUAL IMPAIRMENT IN ONE EYE, PATIENT IS STILL UNDER TREATMENT. TREATED WITH TOPICAL CHLORAMPHENICOL AND MOXIFLOXACINE ORALLY. THE HOSPITAL WAS AUDITED BY THE HYGIENE EXPERTS (MICROBIOLOGIST, STERILIZATION EXPERT, HOSPITAL HYGIENIST) FROM THE UNIVERSITY HOSPITAL. MANY TESTS WERE PERFORMED, BUT THERE WAS NO LINK TO ANYTHING THAT WAS USED IN THE OPERATING ROOM OR THAT COULD HAVE CAUSED THE INFECTIONS. THE BALANCED SALT SOLUTION WAS NOT EVALUATED. NO (DEVICE NOT RETURNED).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DATE OF THIS (ORIGINAL) REPORT: (B)(6) 2012. EXPIRATION DATE: 06/23/2015. IF IMPLANTED GIVE DATE: (B)(6) 2012. DATE RECEIVED BY MANUFACTURER: 10/30/2012. DATE RECEIVED BY MANUFACTURER OF ADDITIONAL INFORMATION ON FOLLOW UP #2: 01/14/2013. REASON FOR NON-EVALUATION: THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. MANUFACTURE DATE: 06/23/2012. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    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.THE MANUFACTURING RECORD REVIEW SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    ABBOTT MEDICAL OPTICS IN (B)(6) 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 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ENDOSOL BALANCED SALT SOLUTION