BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11882411 · Received May 26, 2021

    Report

    Report Number
    2648035-2021-07878
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 27, 2021
    Report Date
    May 25, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474610521
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT, AND ETHNICITY: UNKNOWN/ NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT EXPLANTED. INITIAL REPORTER EMAIL ADDRESS: UNKNOWN/NOT PROVIDED. INITIAL REPORTER TELEPHONE NUMBER: (B)(6). DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE LENS REMAINS IMPLANTED AND THE CUSTOMER REPORTED "FLUSHING OUT" THE FOREIGN MATERIAL FROM THE LENS. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: BASED ON THE MANUFACTURING RECORDS REVIEW AND HISTORICAL COMPLAINT REVIEW, THERE IS NO INDICATION OF A PRODUCT MALFUNCTION OR PRODUCT QUALITY DEFICIENCY. NO NONCONFORMITY REPORT, DOCUMENTATION OR LABELING CHANGES, AND ESCALATIONS ARE REQUIRED. A SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. CONCLUSION: THE CUSTOMER REPORTED USING A NON-JNJ INSERTION SYSTEM (ALCON MONARCH INJECTOR) WITH THE JNJ LENS. PER DFU (Z311387, DFU, TECNIS EYHANCE IOL, MODEL ICB00 INT, REV. B), "JOHNSON & JOHNSON SURGICAL VISION, INC. RECOMMENDS USING THE UNFOLDER PLATINUM 1 SERIES IMPLANTATION SYSTEM OR AN EQUIVALENT INSERTION INSTRUMENT OR SYSTEM TO INSERT THE TECNIS EYHANCE IOL, MODEL ICB00, LENSES. ONLY INSERTION INSTRUMENTS THAT HAVE BEEN VALIDATED AND APPROVED FOR USE WITH THIS LENS SHOULD BE USED." 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON NOTICED FIBER ON LENS AFTER IMPLANTATION. SURGEON WAS ABLE TO REMOVE THE FIBER OUT OF ANTERIOR CHAMBER. IT WAS NOTED THAT SURGEON WAS USING ALCON MONARCH INJECTOR WITH THEIR "D" CARTRIDGE. THIS INCIDENT WAS NOT PRESENT WHEN SHE CHANGED TO USING OUR J&J PLATINUM INJECTOR AND RESPECTIVE CARTRIDGE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780062 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ICB00 05050474610521

    Patients

    Seq Age Sex Outcome Treatment
    1