BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL

    MDR report key: 6443172 · Received March 29, 2017

    Report

    Report Number
    2648035-2017-00578
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    February 28, 2017
    Report Date
    July 5, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    UDI-DI
    05050474561755
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 04/13/2017. DEVICE RETURNED TO MANUFACTURER? YES. DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS RETURNED AT THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION AT 10X MICROSCOPE MAGNIFICATION SHOWED THAT THE LENS WAS CUT IN PIECES, POSSIBLY RELATED TO THE EXPLANT PROCESS. LOOSE PARTICLES AND A SCRATCH MARK WERE OBSERVED ON THE LENS SURFACE. TWO VIDEOS OF THE PROCEDURE WERE PROVIDED AND WERE EVALUATED. IT WAS CLEARLY SEEN THAT THE LENS WAS MANIPULATED WITH A SHARP TOOL DURING THE SURGERY. SOME MARKS/SCRATCHES WERE OBSERVED IN THE OPTIC ZONE AND ON THE EDGE OF THE LENS, WHICH COULD BE RELATED TO THE HANDLING OF THE LENS. THE CUSTOMER'S REPORTED COMPLAINT WAS VERIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE: EXACT DATE OF EXPLANT IS UNKNOWN. WEEK OF (B)(6) 2017 WAS PROVIDED AS TIMEFRAME OF WHEN THE EXPLANT WAS CONDUCTED. (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, INTRAOCULAR LENS (IOL) MODEL NUMBER PCB00V THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE UNITED STATES, IOL MODEL NO. PCB00, WHICH FALLS UNDER PMA P980040. (B)(4). DEVICE EVALUATION: THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED AT THE MANUFACTURING SITE; THEREFORE PRODUCT TESTING COULD NOT BE PERFORMED. A PHOTO OF THE IMPLANTED LENS WAS PROVIDED AND WAS EVALUATED. SOME MARKS THAT APPEARED TO BE SCRATCHES COULD BE OBSERVED IN THE OPTIC ZONE AND IN THE EDGE OF THE LENS. HOWEVER, THE ISSUE WAS OBSERVED AFTER THE IMPLANTATION OF THE LENS AND IT COULD BE RELATED TO HANDLING ISSUES. THE CUSTOMER'S REPORTED COMPLAINT WAS VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE INTRAOCULAR LENS WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH REVEALED THAT NO ADDITIONAL COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE DFU STATES TO INSPECT THE DEVICE FOR PARTICLES, MATERIAL DEPOSITS, DAMAGE, OR OTHER DEFECTS. AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: UPON FURTHER REVIEW OF THE VIDEOS PROVIDED, IT WAS OBSERVED THAT ONE OF THE HAPTICS WAS STUCK TO THE OPTIC AFTER INSERTION INTO THE PATIENT'S EYE. THE HAPTIC WAS UNFOLDED AFTER MANIPULATION BY THE SURGEON. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT JUST AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), TWO SCRATCH MARKS WERE OBSERVED AROUND THE CENTER PART AND THE EDGE PART OF THE OPTIC. NO VISUAL ACUITY ISSUE WAS IDENTIFIED UP TO TWO DAYS POST-OPERATION. HOWEVER, THE PATIENT HAD TROUBLE SEEING SINCE THEN AND THE SURGEON WAS PLANNING TO TALK TO THE PATIENT AND DECIDE WHETHER TO EXPLANT THE LENS OR NOT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017, AND IT WAS LEARNT THAT THE LENS WAS EXPLANTED THE PREVIOUS WEEK. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225384 TECNIS OPTIBLUE ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS PCB00V 05050474561755

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention