BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 7268168 · Received February 13, 2018

    Report

    Report Number
    2648035-2018-00236
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    December 5, 2017
    Report Date
    May 15, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474558113
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH: UNKNOWN/ NOT PROVIDED. SEX/GENDER: UNKNOWN/ NOT PROVIDED. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). THE INTRAOCULAR LENS WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. (B)(6). (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE VIDEO TAKEN DURING THE PROCEDURE WAS EVALUATED AND IT WAS CONCLUDED THAT THERE IS A POSSIBILITY OF COMPONENT MISS ALIGNMENT. BASED ON THIS THE COMPLAINT REPORTED WAS CONFIRMED. HOWEVER, ANOTHER ROOT CAUSE COULD BE THE INADEQUATE USE OF VISCOELASTIC. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE LENS WAS DISCARDED AS STATED THE INITIAL REPORT; THEREFORE, NO SAMPLE EVALUATION WAS POSSIBLE. THE COMPLAINT REPORTED CANNOT BE CONFIRMED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU PROVIDE THE CUSTOMER WITH PROPER USAGE INSTRUCTIONS AND GUIDELINES. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON IMPLANTED THE INTRAOCULAR LENS (IOL), SHE HAD TO USE MORE FORCE TO SCREW THE PLUNGER THAN USUAL AND AFTER THE IOL ENTERED THE EYE SHE DISCOVERED A BIG STAR SHAPED DAMAGE ON THE LENS BACK SURFACE. SHE THEN CUT THE LENS INTO SMALL PIECES, REMOVED AND REPLACED IT. AN INCISION ENLARGEMENT WAS PERFORMED. THE PATIENT HAD 20/20 VISION, THE WEEK AFTER SURGERY. THERE WERE NO SUTURES OR VITRECTOMY. THE REMOVED LENS WAS DISCARDED BY THE SURGICAL STAFF. IT WAS STATED DURING FOLLOW UP THAT THERE WAS NO FOREIGN MATERIAL ON THE LENS AND THE AREA OUTSIDE THE ''STAR SHAPED'' ZONE APPEARED TO BE INTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109862 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00 05050474558113

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention