BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 17353779 · Received July 19, 2023

    Report

    Report Number
    3012236936-2023-01861
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    May 23, 2023
    Report Date
    October 26, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474529069
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTIONS A-2 PATIENT AGE AND DATE OF BIRTH, A-4 PATIENT WEIGHT, AND A-5 PATIENT ETHNICITY AND RACE: UNKNOWN/ASKED INFORMATION UNAVAILABLE. SECTION D-6A DATE IMPLANTED: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. SECTION D-6B DATE EXPLANTED: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE, THEREFORE NOT EXPLANTED. SECTION H3-81: THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION REGARDING COMPLAINT HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED WITH DEVICE RETURN: SECTION A-2 PATIENT AGE/DATE OF BIRTH: (B)(6) 1938; SECTION A-3: PATIENT GENDER: FEMALE; SECTION E-1 INITIAL REPORTER TITLE: DR.; SECTION E-1 INITIAL REPORTER FIRST/GIVEN NAME: (B)(6); SECTION E-1 INITIAL REPORTER LAST NAME: (B)(6); SECTION E-2 HEALTH PROFESSIONAL: YES; SECTION E-3 OTHER OCCUPATION: PHYSICIAN. DEVICE VISUAL INSPECTION: SECTION D-9: DEVICE AVAILABLE FOR EVALUATION: YES; SECTION D-9: DEVICE DATE RETURNED TO MANUFACTURER: 19-SEP-2023; SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE COMPLAINT LENS WAS RECEIVED INSIDE OF THE ORIGINAL LENS CASE. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT LENS WAS RECEIVED COATED IN RESIDUE. THE CARTRIDGE WAS INSPECTED FOR ADDITIONAL ALLEGED FOREIGN MATERIAL, NONE WAS IDENTIFIED. THE LENS WILL BE SENT TO EAG FOR FTIR ANALYSIS; A MATERIAL ANALYSIS REPORT WAS REQUESTED FOR THE FOREIGN MATERIAL. PER EAG LABORATORIES, THE MATERIAL IS CONSISTENT WITH A SODIUM SPECIES SIMILAR TO SODIUM HYALURONATE. COMPLAINT ISSUE OF DC-FOREIGN MATERIAL - LOOSE WAS IDENTIFIED DURING PRODUCT EVALUATION; HOWEVER, BASED ON THE COMPLAINT INVESTIGATION RESULTS THE COMPLAINT ISSUE COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION COULD BE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NON-PRELOADED ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS INSERTED AND DEBRIS WAS OBSERVED ON THE POSTERIOR ASPECT OF THE IOL. THE INCISION WAS ENLARGED TO REMOVE AND REPLACE THE IOL SINCE THE DEBRIS COULD NOT BE CLEARED AWAY; THE DETAILS OF THE REPLACEMENT LENS ARE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826439 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003 05050474529069

    Patients

    Seq Age Sex Outcome Treatment
    1 Female