BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYMFONY

    MDR report key: 7329393 · Received March 9, 2018

    Report

    Report Number
    9614546-2018-00238
    Event Type
    Injury
    Date Received
    March 9, 2018
    Report Date
    July 3, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS TWO (2) OF TWO (2); 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 RECORD CANNOT BE REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED, BUT THE BEST ESTIMATE DATE IS BETWEEN (B)(6) 2017 & (B)(6) 2018. THE LENS REMAINS IMPLANTED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD BILATERAL SYMFONY INTRAOCULAR LENSES (IOLS) IMPLANTS ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT IS VERY UPSET WITH THE OUTCOME. REPORTEDLY, THE PATIENT HAD DIFFICULTIES WITH THE PHYSICIAN WHO CLAIMED THAT SHE CAN ONLY REPLACE THE IOL WITHIN A YEAR OF THE ORIGINAL IMPLANT DATE, WHICH WAS ABOUT A WEEK FROM THE DATE THE PATIENT CALLED. THE PATIENT IS ALSO VERY SAD, ANXIOUS, AND UPSET BECAUSE SHE WAS VERY ACTIVE PRIOR TO SURGERY AND NOW HAS BEEN HOME BOUND FOR A YEAR DUE TO VISUAL IMPAIRMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170081 TECNIS SYMFONY MULTIFOCAL IOLS POE JOHNSON & JOHNSON SURGICAL VISION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other