BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11897840 · Received May 27, 2021

    Report

    Report Number
    9614546-2021-07185
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 27, 2021
    Report Date
    February 10, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    HQL
    UDI-DI
    05050474658981
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION D10: IN THE INITIAL REPORT MODEL OF CARTRIDGE USED WAS PROVIDED AS UNKNOWN, HOWEVER, THE MODEL CARTRIDGE IS 1MTEC30 AND INJECTOR USED WERE (PLATINUM). LOT NUMBERS REMAIN UNKNOWN AS THEY WERE NOT PROVIDED. ADDITIONAL INFORMATION: NO COMPLAINT LENS WAS RECEIVED. THE ALLEGED FOREIGN MATERIAL (TWO PIECES) WAS RETURNED BY THE CUSTOMER. THE ORIGINAL LENS CASE WAS RECEIVED. THE ALLEGED FOREIGN MATERIAL SAMPLES WERE FORWARDED TO EAG LABORATORIES FOR FURTHER EVALUATION. FOREIGN MATERIAL SAMPLE #1 IS IDENTIFIED AS POLYPROPYLENE AND FOREIGN MATERIAL #2 IDENTIFIED AS A POLYESTER. THE COMPLAINT ISSUE WAS CONFIRMED FOR BOTH RETURNED FOREIGN MATERIAL SAMPLES. AN FIELD FAILURE EVALUATION (FFE)/FAILURE INVESTIGATION (FI) WILL BE OPENED TO FURTHER INVESTIGATE THE COMPLAINT ISSUE. A FAILURE INVESTIGATION (FI) WAS PERFORMED. PRODUCT EVALUATION: THE COMPLAINT ISSUE WAS CONFIRMED FOR BOTH RETURNED FOREIGN MATERIAL SAMPLES. BOTH THE SWABROD AND TEXWIPESALPHA ARE MATERIALS USED DURING MANUFACTURING. FAILURE INVESTIGATION DECISION: ACRYLIC 1PIECE IOLS PROCESS FAILURE MODE AND EFFECT ANALYSIS WAS REVIEWED. IN JAN 2020, A FOREIGN MATTER INSPECTION AWARENESS TRAINING WAS PROVIDED TO ALL OPERATORS WORKING AT WORK STATIONS INSPECTING FOR FOREIGN MATTER. ONE NON-CONFORMANCE WAS RAISED FOR A PRODUCT MANUFACTURED AFTER COMPLETION OF THE FOREIGN MATTER INSPECTION AWARENESS TRAINING: NR-0152018. ONE FI WAS RAISED FOR A PRODUCT MANUFACTURED AFTER COMPLETION OF THE FOREIGN MATTER INSPECTION AWARENESS TRAINING: FI-0000710. CONSIDERING THE RELATED RISK IS MEDIUM, AND THAT SINCE THE INITIATION OF THE LAST FOREIGN MATTER RELATED NC AND FOREIGN MATTER RELATED FAILURE INVESTIGATION NO ADDITIONAL NON-CONFORMANCE'S (NC'S) OR FI'S FOR PRODUCTS WITH A MANUFACTURING DATE LATER THAT JAN 2020 WERE INITIATED, NO FURTHER ESCALATION IS DEEMED REQUIRED. CONCLUSION: THE FOLLOWING POTENTIAL ASSIGNABLE CAUSES ARE IDENTIFIED: MAN: OMISSION ERRORS. THE INVOLVED OPERATORS PERFORMING VISUAL INSPECTION DURING PRE-PACKAGING AND FINAL PACKAGING OMITTED TO PERFORM THOROUGH VISUAL INSPECTION, LEADING TO ACCEPTING A NON-CONFORMING UNIT. MAN: LEARNING GAP ERRORS: OPERATOR WORKING AT THE FINAL PACKAGING STATION WAS UNQUALIFIED AND UNAWARE OF THE REQUIREMENT TO INSPECT FOR FOREIGN MATTER. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    TELEPHONE NUMBER: (B)(6). THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE SURGEON NOTICED AN INTRAOCULAR LENS (IOL) HAD A PLASTIC FIBER STUCK ON THE LENS BEFORE INSERTION. THE PATIENT IS FINE AND ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL) WAS IMPLANTED AS A REPLACEMENT. THROUGH FOLLOW-UP, IT WAS LEARNED THERE WAS PATIENT CONTACT, AND ONCE THE LENS WAS IMPLANTED, THERE WAS A VISIBLE CLEAR PLASTIC ON THE LENS. IT APPEARED TO BE SIMILAR TO A PIECE OF THE CARTRIDGE. THE PLASTIC FIBER PIECE WAS REMOVED IMMEDIATELY. THE LENS REMAINS IMPLANTED. THERE WAS NO REPORT OF ANY MEDICAL/SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789892 TECNIS IOL INTRAOCULAR LENS HQL AMO MANUFACTURING NETHERLANDS ZCU225 05050474658981

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 1MTEC CARTRIDGE LOT# UNKNOWN| CARTRIDGE, MODEL AND LOT# UNKNOWN