BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_TECNIS SYMFONY TORIC

    MDR report key: 12215959 · Received July 23, 2021

    Report

    Report Number
    9614546-2021-07297
    Event Type
    Injury
    Date Received
    July 23, 2021
    Report Date
    July 23, 2021
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE, WEIGHT, ETHNICITY: INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. MODEL NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED PHONE NUMBER: (B)(6). THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS THE LENS REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. AS THE SERIAL NUMBER OF THE DEVICE IS UNKNOWN NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: SANDOVAL, H., LANE, S., SLADE, S., DONNENFELD, E. D., POTVIN, R., SOLOMON, K.D., EVALUATING ROTATIONAL STABILITY OF AN EXTENDED DEPTH OF FOCUS TORIC INTRAOCULAR LENS USING A SLIT LAMP AND IMAGE-BASED ANALYSIS. (2020), CLINICAL OPHTHALMOLOGY, 14:PP 2405¿2410 AN ATTEMPT HAS 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

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: TITLE: EVALUATING ROTATIONAL STABILITY OF AN EXTENDED DEPTH OF FOCUS TORIC INTRAOCULAR LENS USING A SLIT LAMP AND IMAGE-BASED ANALYSIS. A PROSPECTIVE UNMASKED RANDOMIZED STUDY WAS DONE TO EVALUATE THE ROTATIONAL STABILITY OF A TORIC EXTENDED DEPTH OF FOCUS (EDOF) INTRAOCULAR LENS (IOL), USING EITHER SLIT LAMP EVALUATION OR IMAGE-PROCESSING SOFTWARE. A TOTAL OF 150 EYES WITH CATARACT RECEIVED BILATERAL TORIC EDOF LENSES TECNIS SYMFONY TORIC (JOHNSON AND JOHNSON VISION). FROM 1 DAY TO 3 MONTHS, OF THE 148 EYES WITH AVAILABLE DATA, 17 EYES EXHIBITED LENS ROTATION OF =5 DEGREES AND 3 EYES EXHIBITED LENS ROTATION OF >10 DEGREES OBSERVED BY A SLIT LAMP. IN THE SAME TIME PERIOD, OF 103 EYES WITH AVAILABLE DATA, 3 EYES EXHIBITED LENS ROTATION OF =5 DEGREES AND 1 EYE EXHIBITED LENS ROTATION OF 17 DEGREES (THIS WAS REORIENTED) OBSERVED BY AN IMAGING SYSTEM. FURTHERMORE, 2 EYES OF 150 EXHIBITED SIGNIFICANT ROTATION BETWEEN THE DAY OF SURGERY AND THE 1-DAY VISIT. IN BOTH CASES THE IOL WAS REORIENTED. NO FURTHER INTERVENTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117602 UNK_TECNIS SYMFONY TORIC EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention