BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS ITEC PRELOADED 1-PIECE IOL

    MDR report key: 10632227 · Received October 5, 2020

    Report

    Report Number
    2648035-2020-00738
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    September 11, 2020
    Report Date
    November 23, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474558281
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D10: DEVICE AVAILABLE FOR EVALUATION: YES, RETURNED TO MANUFACTURER ON 10/12/2020. SECTION H3: DEVICE RETURNED TO MANUFACTURER: YES DEVICE EVALUATION: SAMPLE WAS RECEIVED AT AMO PUERTO RICO MANUFACTURING / JOHNSON AND JOHNSON SURGICAL VISION. VISUAL INSPECTION USING MAGNIFICATION WAS PERFORMED TO THE RETURNED SAMPLE: ONLY LENS RETURNED. LENS WAS OBSERVED WITH A CUT. LOOSE FIBERS/PARTICLES WERE OBSERVED ON LENS RELATED THE HANDLING OF THE UNIT OUT OF A STERILE ENVIRONMENT. RESIDUES OF LUBRICANT MATERIAL WAS ALSO OBSERVED ON LENS. 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. BASED ON THE ANALYZED OF THE RETURNED, THERE IS NO INDICATION OF PRODUCT QUALITY DEFICIENCY. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THERE ARE NO DISCREPANCIES FOUND DURING THE MRR (MANUFACTURING RECORD REVIEW) RELATED TO THIS COMPLAINT. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. A SEARCH IN COMPLAINT SYSTEM REVEALED NO ADDITIONAL COMPLAINT FOLDERS FOR THIS PO NUMBER. 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 · 1

    AGE/DATE OF BIRTH: UNKNOWN, INFORMATION NOT PROVIDED. IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS LENS WAS REMOVED/REPLACED IN THE INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS DENSE CATARACT AND THE DOCTOR REPORTED FOLDING PROBLEMS WHEN INSERTED LENS INTO EYE. THERE WAS NO PATIENT INJURY AND A 3-PIECE INTRAOCULAR LENS (IOL) WAS IMPLANTED SUCCESSFULLY. IT WAS LEARNED THAT THE HAPTICS WERE STUCK ON THE OPTIC THEREBY MAKING THE IOL TO FOLD OVER. THE LENS WAS FULLY IMPLANTED, REMOVED SUCCESSFULLY AND REPLACED DURING THE SAME PROCEDURE AFTER VITRECTOMY WITH A SULCUS IOL. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097163 TECNIS ITEC PRELOADED 1-PIECE IOL MONOFOCAL IOLS HQL JOHNSON & JOHNSON SURGICAL VISION, INC. PCB00 05050474558281

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention