BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SYNERGY OPTIBLUE IOL

    MDR report key: 12523908 · Received September 23, 2021

    Report

    Report Number
    2020664-2021-07439
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    May 3, 2021
    Report Date
    January 27, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    UDI-DI
    05050474652545
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: WE INADVERTENTLY CHOSE THE INCORRECT CODE IN OUR INITIAL REPORT SUBMITTED. THE CORRECT CODE IS 2140 - VISUAL DISTURBANCES INSTEAD OF 2138 - VISUAL IMPAIRMENT. SECTION H6: HEALTH EFFECT: CLINICAL CODE: 2140 UPDATED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9 - DATE RETURNED TO MANUFACTURER: 15TH DECEMBER 2021 DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED VISCOELASTIC RESIDUE ON THE OPTIC BODY AND HAPTIC. THE LENS WAS CLEANED, AND THE LENS PRESENTED WITH A DETACHED HAPTIC. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED, AND NO PRODUCT DEFICIENCY WAS IDENTIFIED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE PRODUCT EVALUATION COULD NOT BE PERFORMED BECAUSE THE PRODUCT HAS NOT YET BEEN RECEIVED. IF PRODUCT IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURING RECORD EVALUATION: 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. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED

    Additional Manufacturer Narrative · 1

    AGE OR DOB, WEIGHT, ETHNICITY: INFORMATION UNKNOWN/ NOT PROVIDED. TELEPHONE NUMBER: (B)(6). POST OFFICE OR ZIP CODE: (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE POST-OPERATIVE CHECK UPS ((B)(6) 2021) THE PATIENT COMPLAINED ABOUT WAVY, UNSETTLED VISION, NOT SEEING WELL FAR AND NOT READING WELL. ON (B)(6) THE INTRAOCULAR LENS (IOL) MODEL ZFR00V WAS REMOVED AND REPLACED WITH A 1 PIECE MONOFOCAL SENSAR IOL. VISUAL ACUITIES AND OTHER MEASUREMENTS ARE PROVIDED BELOW FOR THE CORRESPONDING VISITS. HOWEVER, NO READINGS WERE PROVIDED POST EXPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(6) 2021: VISUAL ACUITY WITHOUT CORRECTION: 1.0 = >> NEAR 0.63 WITH S + 1.00 EXTRA 0.80. (B)(6) 2021: VISUAL ACUITY WITHOUT CORRECTION: 0.7+ >> AFTER CORRECTION: S + 0.50 = C -1.00 X 100. (B)(6) 2021: VISION WITHOUT CORRECTION: 0.9 = >> AFTER CORRECTION: S + 0.50 = C -0.75 X 100 1.1 = MEASURED VALUES ZEISS IOL MASTER (B)(6) 2021. AL: 25.18 MM, ACD: 2.44MM, LT: 5.92MM, HRV: 11.6 MM, SE: 43.37D SD 0.02D, K1 43.04D @ 91, K2 43.70 D @ 1, C-0.66D @ 91. CALCULATION WITH THE SRK / T A CONST 119.30 >> +16.50 D REF -0.06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421004 TECNIS SYNERGY OPTIBLUE IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZFR00V 05050474652545

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention