BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13238956 · Received January 12, 2022

    Report

    Report Number
    3012236936-2022-00084
    Event Type
    Injury
    Date Received
    January 12, 2022
    Date of Event
    December 16, 2021
    Report Date
    March 14, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MFK
    UDI-DI
    05050474751262
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE/LOT HISTORY RECORD AND COMPLAINT TRENDING 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. RETURNED TO MANUFACTURER ON: FEB. 7, 2022. SECTION H3. DEVICE EVALUATED MANUFACTURER? YES. DEVICE EVALUATION: TWO LENSES WERE RECEIVED INSIDE A PLASTIC BAG STUCK TO PIECES OF STYROFOAM. NO HANDPIECES WERE RETURNED. NO WAY TO DIFFERENTIATE BETWEEN THE LENSES WAS RECEIVED. VISUAL INSPECTIONS FOR BOTH LENSES UNDER MAGNIFICATION REVEALED THAT THE LENSES WERE RECEIVED WITH A CUT ON THE OPTIC BODY, WHICH IS CONSISTENT WITH LENS THAT WAS HANDLED DURING EXPLANT. THE LENSES WERE CLEANED, AND NO ISSUE RELATED TO OR COULD HAVE CONTRIBUTED TO VISUAL ISSUES WERE OBSERVED. NO DEFECTS RELATED TO OR COULD HAVE CONTRIBUTED TO VISUAL ISSUES WERE OBSERVED. THE COMPLAINT ISSUE COULD NOT BE CONFIRMED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. 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 · 0

    ADDITIONAL INFORMATION: RECEIVED NEW INFORMATION THAT THE ISSUE WAS THAT INITIAL POST-OP WAS SHARP/VERY CLEAR. BUT AS TIME WENT BY, SEES HALOS/HAZE. CAN READ STREET SIGNS BUT NOT SO CLEAR. PRE-OP VISION REFRACTION: RIGHT EYE (OD), 20/20. POST-OP VISION REFRACTION: OD, 20/20. FOLLOW-UP REFRACTION POST LENS REPLACEMENT WAS REFRACTION 20/20; PATIENT VERY HAPPY WITH REPLACEMENT LENSES. FIELDS BELOW UPDATED TO REFLECT NEW PATIENT CODES RECEIVED. SECTION H6: HEALTH EFFECT: CLINICAL CODE: HALO. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT COMPLAINT OF DISTORTED NOT CLEAR VISION TO RIGHT EYE. THE LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON (PANOPTIX) IOL. THE PATIENT IS HAPPY WITH THE NEW LENS. NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781455 TECNIS IOL LENS, MULTIFOCAL INTRAOCULAR MFK AMO PUERTO RICO MFG. INC. DFW150 05050474751262

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention