BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 12536967 · Received September 27, 2021

    Report

    Report Number
    2020664-2021-07538
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Report Date
    January 3, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731851
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 10/4/2021. SECTION H3. DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THE ALLEGED FOREIGN MATERIAL WAS RECEIVED IN A SPECIMEN CUP, WHICH WAS THEN SENT TO EAG LABORATORIES FOR FURTHER ANALYSIS. A MATERIAL ANALYSIS REPORT WAS REQUESTED FOR THE FOREIGN MATERIAL, AND THE PRODUCT WAS RECEIVED BY EAG LABORATORIES. PER EAG LABORATORIES, FTIR ANALYSIS INDICATES THAT THE FOREIGN MATERIAL IS CONSISTENT WITH A PROTEIN-BASED FIBER (E.G., HAIR/FUR, SILK OR WOOL). THE FTIR SPECTRUM RAW DATA OUTPUT FILE GENERATED BY EAG LABORATORIES WAS THEN COMPARED AGAINST THE AÑASCO MANUFACTURING PROCESS FTIR LIBRARY AND DID NOT YIELD ANY RESULTS WITH AT LEAST A 0.90000 CORRELATION. THE TOP HIT WAS ¿N/A1PC ALUMINUM PLATE¿ WITH A 0.267232 CORRELATION. THE COMPLAINT ISSUE WAS CONFIRMED, HOWEVER BASED ON THE FTIR RESULT THE FOREIGN MATERIAL IS NOT PART OF THE DEVICE COMPONENTS. HOWEVER, THE ORIGIN OF THE ALLEGED FOREIGN MATERIAL CANNOT BE DETERMINED TO BE PART OF MANUFACTURING PROCESS AND IS THEREFORE INCONCLUSIVE. THROUGHOUT THE MANUFACTURING PROCESSES THERE ARE VARIOUS CLEANING OPERATIONS AND 100% VISUAL INSPECTION UTILIZING MICROSCOPE MAGNIFICATION STEPS THAT WOULD HAVE IDENTIFIED AND DISCARDED A LENS WITH A SIMILAR PARTICULATE OR SUBSTANCE AS REQUIRED BY OUR APPROVED PROCEDURES. THE MANUFACTURING PROCESS IS PERFORMED INSIDE A REGULATED CLEAN ROOM CLASS 6 MANUFACTURING ROOM THAT REQUIRES FULL GOWNING BEFORE ENTERING THE ROOM. NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORD REVIEW: THE MANUFACTURING PROCESS RECORD WAS EVALUATED AND REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS WERE RECEIVED FROM THIS PRODUCTION ORDER. 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, WEIGHT, AND ETHNICITY: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. IF EXPLANTED, GIVE DATE: UNKNOWN/NOT PROVIDED. ATTEMPTS HAVE BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, NO DEFINITIVE 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 AN INTRAOCULAR LENS (IOL) HAD A FIBER WRAPPED AROUND IT AND THERE WAS PATIENT CONTACT WITH THE FIBER AND LENS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429278 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown