BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11318610 · Received February 11, 2021

    Report

    Report Number
    2648035-2021-07155
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Report Date
    April 5, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THE DEVICE MODEL AND SERIAL NUMBER WERE PROVIDED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: SECTION D1: BRAND NAME: TECNIS IOL SECTION D2: COMMON DEVICE NAME: TECNIS ITEC PRELOADED DEVICE PRODUCT CODE: HQL SECTION D4: ADDITIONAL DEVICE INFORMATION PRODUCT MODEL: PCB00 CATALOG NUMBER: PCB0000200 SERIAL NUMBER: (B)(6). EXPIRATION DATE: 7/24/2023 UDI #: (B)(4) SECTION G4: PMA NUMBER P980040 SECTION H4: DEVICE MANUFACTURE DATE: 7/24/2020 DEVICE EVALUATION: PRODUCT TESTING COULD NOT BE PERFORMED SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. AS PER THE INFORMATION PROVIDED PRODUCT IS NOT AVAILABLE. IF THE PRODUCT IS RETURNED REGARDING THIS EVENT THE CASE WILL BE REOPENED TO COMPLETE PRODUCT EVALUATION. THEREFORE, THE REPORTED ISSUE COULD NOT BE PERFORMED AND, PRODUCT QUALITY DEFICIENCY COULD NOT BE DETERMINED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. HISTORICAL DATA ANALYSIS: A SEARCH OF COMPLAINTS REVEALED ONE ADDITIONAL COMPLAINT HAS BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER, BUT IT IS NOT RELATED TO THIS COMPLAINT. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A QUALITY PRODUCT 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 · 1

    DATE OF EVENT: UNKNOWN, NOT PROVIDED. THE BEST ESTIMATE IS (B)(6) 2021. IF IMPLANTED; GIVE DATE: N/A (NOT APPLICABLE). LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. IF EXPLANTED; GIVE DATE: N/A (NOT APPLICABLE). LENS WAS REMOVED/REPLACED DURING THE SAME PROCEDURE. PMA/510(K) #: UNKNOWN, AS PRODUCT INFORMATION WAS NOT PROVIDED. DEVICE MANUFACTURER DATE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH ANOTHER LENS BECAUSE THE LENS WAS NOTED TO HAVE VERY SIGNIFICANT SCRATCHES ON IT. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215250 TECNIS IOL TECNIS ITEC PRELOADED HQL AMO PUERTO RICO MFG. INC. PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1