BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13979804 · Received April 1, 2022

    Report

    Report Number
    3012236936-2022-00841
    Event Type
    Injury
    Date Received
    April 1, 2022
    Report Date
    April 1, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE/DATE OF BIRTH: AGE RANGE BETWEEN 64 ± 11 (MEAN ± SD). WEIGHT & ETHNICITY: INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: DATE ARTICLE ACCEPTED IS (B)(6) 2021. A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT EXPLANTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CITATION: BRAR, S., RATHOD, D.P., NIKHIL, R.P., GANESH, S. (2021). CLINICAL OUTCOMES, PREDICTABILITY AND ROTATIONAL STABILITY FOLLOWING IMPLANTATION OF EYECRYL TORIC VERSUS TECNIS TORIC INTRAOCULAR LENSES¿A COMPARATIVE STUDY. INT OPHTHALMOL. 41(1), PP. 3769-3780. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: CLINICAL OUTCOMES, PREDICTABILITY AND ROTATIONAL STABILITY FOLLOWING IMPLANTATION OF EYECRYL TORIC VERSUS TECNIS TORIC INTRAOCULAR LENSES¿A COMPARATIVE STUDY. A RETROSPECTIVE STUDY WAS DONE TO COMPARE THE VISUAL OUTCOMES, PREDICTABILITY AND ROTATIONAL STABILITY FOLLOWING IMPLANTATION OF EYECRYL TORIC VERSUS TECNIS TORIC INTRAOCULAR LENSES. A TOTAL OF 100 EYES FROM 78 PATIENTS WERE INCLUDED IN THIS STUDY WHO UNDERWENT PHACOEMULSIFICATION USING THE FOLLOWING IOLS: EYECRYL TORIC IOL (N=50 EYES), AND TECNIS TORIC IOL (N=50 EYES). AT 1ST WEEK AFTER SURGERY, THERE WAS A SIGNIFICANT ROTATION OF THE TORIC IOL (>10 DEGREES) IN TECNIS TORIC GROUP REQUIRING IOL RE-POSITIONING (N=2 EYES). THESE IOLS WERE RE-POSITIONED ON THE SAME DAY, AFTER WHICH THEY REMAINED STABLE AT THE SUBSEQUENT VISITS. AT 6 MONTHS POST OP, TECNIS TORIC GROUP HAD POST-OP ROTATION BETWEEN 11 AND 15 DEGREES (N=3 EYES). THESE WERE NOT RE-ALIGNED AND WERE LEFT AS IT IS. THE MEAN POST-OP ROTATION WAS 4.44 ± 2.77 DEGREES IN TECNIS TORIC GROUPS. THIS REPORT IS FOR THE INTRAOCULAR LENS, MODEL ZC150. SEPARATE REPORTS ARE BEING SUBMITTED FOR THE OTHER TORIC MODELS ZCT-100, 225, 300, 375, 450, 525, 600, 700, 800. IT IS NOT CLEAR WHICH COMPLICATION OCCURRED IN THE EYES IMPLANTED WITH A TORIC MODEL. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227924 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. ZCT150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention