BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY IOL

    MDR report key: 14182783 · Received April 22, 2022

    Report

    Report Number
    3012236936-2022-00946
    Event Type
    Injury
    Date Received
    April 22, 2022
    Date of Event
    March 31, 2022
    Report Date
    July 25, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474652507
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF BIRTH: THE COMPLETE DATE OF BIRTH WAS NOT PROVIDED, ONLY MONTH AND YEAR ((B)(6) WERE PROVIDED. WEIGHT AND ETHNICITY: UNKNOWN/NOT PROVIDED. EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. DATE RETURNED TO MANUFACTURER: MAY 6, 2022. SECTION H3. DEVICE EVALUATED MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE LENS WAS RECEIVED CUT AND WITH A HAPTIC DETACHED. THE LENS WAS CLEANED AND, NO ISSUES THAT COULD CONTRIBUTE TO VISUAL DISTURBANCES OR ISSUES. BASED ON THE RETURN CONDITION OF THE LENS, NO FURTHER PRODUCT EVALUATION COULD BE PERFORMED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY OR PRODUCT MALFUNCTION AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT SUFFERED FROM HALOS AND GLARES IN THEIR RIGHT EYE. THE PATIENT COULD SEE THE ACTUAL OPTIC RINGS IN THE DIM LIGHT CONDITION. THE SURGEON DETERMINED THAT THE PATIENT COULD NOT ADAPT TO THE INTRAOCULAR LENS (IOL). THE PATIENT'S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THERE WAS AN EXPLANT PERFORMED WHERE THE REPLACEMENT LENS WAS A MONOFOCAL IOL. NO FURTHER INTERVENTIONS WERE PERFORMED. THE PATIENT IS TEMPORARILY IMPAIRED. VISION PRE-OPERATIVE: FAR: 0.5 (DECIMAL). VISION POST-OPERATIVE: FAR: 0.8. POST-OP VISUAL ACUITY IS 0.9 DECIMAL. NO COMPLAINT REGARDING GLARE & HALOS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714499 TECNIS SYNERGY IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS MFK AMO PUERTO RICO MFG. INC. ZFR00V 05050474652507

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention