BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY TORIC

    MDR report key: 7073779 · Received November 30, 2017

    Report

    Report Number
    9614546-2017-01181
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    September 1, 2017
    Report Date
    April 27, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: UPON FURTHER REVIEW OF THE COMPLAINT FILE IT WAS DISCOVERED THAT THE SERIAL NUMBER OF THE DEVICE WAS KNOWN AT THE TIME OF THE INITIAL REPORT HOWEVER WAS NOT INCLUDED. THEREFORE THE FOLLOWING FIELDS HAVE BEEN UPDATED FROM UNKNOWN TO THE APPLICABLE INFORMATION AS PROVIDED BELOW: SERIAL #: (B)(4), CATALOG #: ZXT375U165, EXPIRATION DATE: 06/07/2022, UDI: (B)(4). MANUFACTURING DATE: 06/07/2017. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 03/07/2018. DEVICE RETURNED TO MANUFACTURER? YES. THE PRODUCT WAS RECEIVED IN A CONTAINER WITH LIQUID. VISUAL INSPECTION WAS PERFORMED; THE LENS WAS CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. CONSIDERING THE CONDITION OF THE LENS, FURTHER ANALYSIS IS NOT POSSIBLE. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER AND RELATED DOCUMENT REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THERE WAS NO DISCREPANCY FOUND DURING THE REVIEW. A SEARCH REVEALED THAT NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS PRODUCTION ORDER. THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER WAS NOT PROVIDED. (B)(4). ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYMFONY INTRAOCULAR LENS (MODEL ZXT375, DIOPTER 16.5) WAS IMPLANTED IN THE RIGHT EYE (OD - OCULUS DEXTER) OF A (B)(6) MALE PATIENT ON (B)(6) 2017. ONE DAY POST-OP THE PATIENT VA (VISUAL ACUITY) WAS REPORTED DOING WELL WITH STILL A BIT OF BLURRINESS. DVA (DISTANCE VISUAL ACUITY) 20/40. ON (B)(6) 2017 THE PATIENT VISITED THE DOCTOR AGAIN AS HE REPORTED A SUDDEN DECREASE IN VISION AND BLURRED VISION IN OD. THE PATIENT STARTED FEELING SICK THE NIGHT BEFORE. THE LENS WAS NOTICED ROTATED ABOUT 70 DEGREES. DVA 20/150. ON (B)(6) 2017 THE PATIENT VISITED THE DOCTOR AGAIN AND HE REPORTED THAT THE VISION CAME IN AND OUT AND THE LENS WAS NOTICED ROTATED TO ABOUT 80 DEGREES. DVA 20/80-1. ON (B)(6) 2017, THE PATIENT VISITED THE DOCTOR AGAIN AND IT WAS REPORTED MECHANICAL COMPLICATION DUE TO OCULAR LENS PROSTHESIS. THERE WAS A HEAVY PIGMENT WITH ELEVATED IOP (INTRAOCULAR PRESSURE). THE PATIENT RECEIVED 1 DROP OF TRAV Z AND 1 DROP OF SIMBINZA AND WAS INSTRUCTED TO USE THESE DROPS IN OD. AS THE LENS KEPT ROTATING ON DIFFERENT AXIS CAUSING CHANGES IN VA, IT WAS DECIDED TO EXCHANGE THE LENS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REVEALED THAT THE LENS WAS SUCCESSFULLY EXPLANTED ON (B)(6) 2017. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852201 TECNIS SYMFONY TORIC MULTIFOCAL IOLS POE ABBOTT MEDICAL OPTICS ZXT375

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention