BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 10631964 · Received October 5, 2020

    Report

    Report Number
    2648035-2020-00736
    Event Type
    Injury
    Date Received
    October 5, 2020
    Report Date
    November 6, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558328
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D10: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D10: RETURNED TO MANUFACTURER ON: 10/12/2020. SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES. DEVICE EVALUATION: THE PRODUCT WAS RECEIVED AT AMO PUERTO RICO MANUFACTURING SITE. VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED TO THE RETURNED SAMPLE: ONLY LENS RETURNED. LENS RETURNED CUT IN TWO PIECES. LOOSE FIBERS/PARTICLES WERE OBSERVED ON LENS PIECES RELATED THE HANDLING OF THE UNIT OUT OF A STERILE ENVIRONMENT. RESIDUES OF LUBRICANT MATERIAL WAS ALSO OBSERVED ON LENS PIECES. THE CONDITION IN WHICH THE SAMPLE RETURNED IS CONSISTENT WITH A LENS THAT WAS IMPLANTED AND REMOVED. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. HISTORICAL DATA ANALYSIS: A SEARCH OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINT FOLDERS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER NUMBER. 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

    EVENT DATE: BEST ESTIMATE IS BETWEEN (B)(6) 2020. (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TECNIS ITEC PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE BECAUSE THE LENS DISLOCATED AFTER IMPLANTATION. VITRECTOMY WAS PERFORMED DURING THE SECONDARY PROCEDURE. THE REPLACEMENT LENS IS A ZA9003, 22.5 DIOPTER, SERIAL NUMBER (B)(4). PATIENT OUTCOME WAS NOT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094646 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558328

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention