BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 15965471 · Received December 12, 2022

    Report

    Report Number
    3012236936-2022-02950
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Report Date
    March 14, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474546905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. BEST ESTIMATE OF DATE OF EVENT IS BETWEEN (B)(6) 2022 AND (B)(6) 2022. TELEPHONE NUMBER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL DEVICE; TECNIS 1-PC OPTIBLUE MONO 6.0MM 28.0D 1-PIECE IOL, MODEL ZCB00V THAT HAS A SIMILAR DEVICE, TECNIS SIMPLICITY PRELOADED 1-PIECE IOL MODEL ZCB00 WHICH IS DISTRIBUTED IN THE UNITES STATES UNDER PMA P980040. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: FEBRUARY 23, 2023. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE LENS WAS CUT IN HALF. THE LENS WAS CLEANED AND FURTHER INSPECTED UNDER MAGNIFICATION AND NO COSMETIC ISSUES WERE OBSERVED. NO OTHER ISSUES WERE OBSERVED WITH THE SUSPECT LENS. THE COMPLAINT ISSUES OF COSMETIC ISSUES AND BLURRY VISION WERE NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LENS WILL BE EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO A LENS SURFACE DEFECT. THROUGH FOLLOW-UP WE LEARNED THAT THE LENS HAS BEEN EXPLANTED AND THAT THE PATIENT COULD NOT SEE VERY WELL WITH THE INITIALLY IMPLANTED LENS. VISION PRE-OP :0.80, POST-OP 1.00. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2181043 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00V 05050474546905

    Patients

    Seq Age Sex Outcome Treatment
    1 Female