BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 12537098 · Received September 27, 2021

    Report

    Report Number
    2020664-2021-07537
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Report Date
    December 1, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731721
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT EVALUATION WAS NOT PERFORMED BECAUSE THE PRODUCT HAS NOT BEEN RETURNED. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND 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 · 0

    SECTION D9. DEVICE AVAILABLE FOR EVALUATION? YES RETURNED TO MANUFACTURER ON: OCT 4, 2021 SECTION H3. DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THE ALLEGED FOREIGN MATERIAL RETURNED IN A SPECIMEN CUP WHICH WAS THEN FORWARDED TO EAG LABORATORIES FOR FURTHER ANALYSIS. A MATERIAL ANALYSIS REPORT WAS REQUESTED FOR THE FOREIGN MATERIAL, AND THE PRODUCT WAS RECEIVED EAG LABORATORIES. PER EAG LABORATORIES, (FOURIER INFRARED SPECTROSCOPY) FTIR ANALYSIS INDICATES THAT THE FOREIGN MATERIAL (FIBER) IS CONSISTENT WITH A POLYESTER MATERIAL. THE COMPLAINT ISSUE WAS CONFIRMED, HOWEVER DUE TO THE LOW CORRELATION (CORRELATION LESS THAN 0.90000) BETWEEN THE FOREIGN MATERIAL AND THE AÑASCO MANUFACTURING PROCESS FTIR LIBRARY IT CANNOT BE CONFIRMED TO BE RELATED TO MANUFACTURING, BECAUSE AÑASCO HAS MANUFACTURING CONTROLS IN PLACE TO PREVENT THE RELEASE OF PRODUCT WITH FOREIGN MATERIAL ON IT, AND THEREFORE NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. 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

    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 THAT 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
    1429565 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731721

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown