BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7365994 · Received March 23, 2018

    Report

    Report Number
    2648035-2018-00414
    Event Type
    Injury
    Date Received
    March 23, 2018
    Date of Event
    October 23, 2017
    Report Date
    June 19, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DURING FOLLOW-UP, THE SERIAL NUMBER WAS PROVIDED. THEREFORE, THE FOLLOWING FIELDS HAVE BEEN UPDATED ACCORDINGLY: BRAND NAME: TECNIS SYMFONY, COMMON DEVICE NAME: MULTIFOCAL IOLS, PRODUCT CODE: POE. MODEL#: ZXR00, SERIAL (B)(4), CATALOG#: ZXR00U0225, EXPIRATION DATE: 04/13/2022, (B)(4). PMA/510(K)#: P980040, MANUFACTURER REPORT NUMBER: SHOULD BEGIN WITH (B)(4). DEVICE MANUFACTURE DATE: 04/13/2017. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS NOT PROVIDED. THE LENS REMAINS IMPLANTED. PMA/510(K) #: UNKNOWN AS THE MODEL NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT PERTAINS TO IOL SERIAL (B)(4); DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND NO DEVIATION WAS FOUND DURING PROCESS RELATED TO THE COMPLAINT ISSUE REPORTED. THERE WAS NO DISCREPANCY FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW). THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION RESULTS 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 AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, AT THE 6-MONTH FOLLOW UP VISIT WITH THE DOCTOR, THE PATIENT REPORTED BEING EXTREMELY BOTHERED BY HALOS AND STARBURSTS DURING THE NIGHT AND WHEN SHE'S NOT WEARING ANY CORRECTIVE GLASSES. THE PATIENT ALSO STATED THAT SHE IS OFTEN MODERATELY BOTHERED BY SENSITIVITY TO LIGHT AND VERY BOTHERED AT TIMES BY POOR LOW LIGHT VISION DURING THE NIGHT AND WHEN NOT WEARING CORRECTIVE GLASSES. THERE ARE NO PLANS FOR INTERVENTION AT THIS TIME. THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) IN THE RIGHT EYE WAS 20/15. REPORTEDLY, THERE WAS NO PATIENT INJURY AND NO PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD ALSO AN INTRAOCULAR LENS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210575 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other