BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 5428979 · Received February 10, 2016

    Report

    Report Number
    2648035-2016-00209
    Event Type
    Injury
    Date Received
    February 10, 2016
    Date of Event
    January 14, 2016
    Report Date
    August 10, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LENS REMAINS IMPLANTED. (B)(6). (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JULY 28, 2016, PROVIDING A CORRECT SERIAL NUMBER. THE FOLLOWING HAVE BEEN UPDATED: (B)(4). CATALOG #: PCB0000220; SERIAL NUMBER: (B)(4); EXPIRATION DATE: 07/14/2018; DEVICE MANUFACTURE DATE: 07/14/2015. DEVICE EVALUATION: EVALUATION AND REVIEW HAS BEEN COMPLETED BASED ON THE UPDATED SERIAL NUMBER. A PRODUCT EVALUATION COULD NOT BE PERFORMED AS TO DATE THE INTRAOCULAR LENS REMAINS IMPLANTED. THE REPORTED ISSUE IS NOT RELATED TO THE LENS AND COULD BE RELATED TO THE SURGERY PROCESS. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. THE PRODUCTION ORDER WAS EVALUATED AND THE DEVICES WERE MANUFACTURED WITHIN SPECIFICATIONS. THE UNITS WERE RELEASED ACCORDING TO SPECIFICATION. NO NON-CONFORMANCE REPORTS WERE IDENTIFIED THAT WERE RELATED TO THE REPORTED COMPLAINT. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE LENSES. BASED ON THE MANUFACTURING RECORDS, LABELING REVIEW AND THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE INTRAOCULAR LENS (IOL) HAD TO BE CUT IN THE EYE AND REMOVED BEFORE A NEW IOL COULD BE IMPLANTED. ACCORDING TO THE SURGEON THE DESCEMET FOLDS AND THE MILD POST-OPERATIVE IRRITATION COULD BE CONSEQUENCES OF THE LONGER DURATION OF THE SURGERY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: TO DATE THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED AND THE CUSTOMER'S REPORTED COMPLAINT COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEWS: SINCE THE SERIAL NUMBER IS UNKNOWN THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE INTRAOCULAR LENSES. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING REMOVAL OF THE FIRST LENS, A NEW TECNIS LENS WAS IMPLANTED. FURTHER INFORMATION PROVIDED BY THE DOCTOR ON (B)(6) 2016, INDICATED THAT AT DAY 1 (ONE) POST OP, DESCEMET WRINKLES, IOL ENDOCAPSULATION, AND A LITTLE IRRITATION WERE NOTED. VISUAL ACUITY (VA) PRE OPERATIVE: CCS 0,6. VISUAL ACUITY (VA) POST OPERATIVE: S.C. (UNCORRECTED) 0,5 GBN. NO SECONDARY SURGERY/MEDICAL INTERVENTION REPORTED. DELAY 40 MINUTES, EXTENSION OF THE DURATION OF SURGERY. THIS REPORT REPRESENTS THE REPLACEMENT LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84111 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other