BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 18271779 · Received December 5, 2023

    Report

    Report Number
    3012236936-2023-03080
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    October 10, 2023
    Report Date
    February 27, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE FOLLOWING FIELDS WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: SECTION B5: ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER INDICATED THAT THE CARTRIDGE LUBRICATION USED WAS ONLY PROVISC; NO COMBINATION WHEN LOADING LEN. THAT PROVISC WAS INTRODUCED INTO THE CARTRIDGE FROM THE CARTRIDGE CANOPY. THE AVERAGE DWELL TIME IS 0-2 MINUTES. THE SURGICAL TECH PERFORMS THE INITIAL MOVEMENT OF THE LENS (AS TAUGHT BY THE REP). THE SURGICAL TECH DOES THE FIRST TWIST. THE LENS PASSES THE DWELL POSITION AND IS THEN TWISTED TWICE BY THE SURGICAL TECH. IT IS THEN HANDED OVER TO THE SURGEON. WHEN ADVANCING THE LENS THE SURGICAL TECH IS MAKING COMPLETE 2 COMPLETE TURNS. WITH REGARDS TO THIS EVENT, IT WAS INDICATED THAT THE DOCTOR WOULD NOT USE THE LENS AND IT IS UNKNOW IF THE TIP OF CARTRIDGE WAS DAMAGED, IF THE HAPTIC OR OPTIC WAS DAMAGED AND IF THE DAMAGE WAS DUE TO ERROR. IT WAS CONFIRNED THAT THE CARTRIDGE OR LENS DID NOT TOUCH THE EYE AND THAT THE PROCEDURE WAS COMPLETED WITH THE SAME LENS MODEL AND DIOPTER. IT WAS REPORTED THAT THERE WAS NO CAPSULE TEAR, NO UNPLANNED VITRECTOMY, NO SUTURES AND NO MEDICATIONS OUTSIDE THE STANDARD OF CARE REQUIRED. SECTION D10, CONCOMITANT MEDICAL PRODUCTS: PROVISC. SECTION E1: TITLE (E.G., MR., MS.): DOCTOR SECTION E1: FIRST/GIVEN NAME: (B)(6). SECTION E1: LAST NAME: (B)(6). SECTION E1: EMAIL ADDRESS: (B)(6). SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION E2: HEALTH PROFESSIONAL? YES. SECTION E3: OCCUPATION: PHYSICIAN. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D9: RETURNED TO MANUFACTURER ON: JAN 22, 2024. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE RECEIVED COMPLAINT LENS WAS VISUALLY INSPECTED UNDER MAGNIFICATION. THE LENS WAS OBSERVED TO BE COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED REVEALING SCRATCHES ON THE SURFACE OF THE LENS, AND DAMAGE ON THE HAPTICS. THE COMPLAINT SIMPLICITY WAS EVALUATED AND THE CARTRIDGE TIP WAS OBSERVED TO BE CRACKED. OPHTHALMIC VISCOELASTIC DEVICE (OVD) WAS OBSERVED TO BE DISPERSED THROUGHOUT THE CARTRIDGE INDICATING THAT AN ADEQUATE AMOUNT OF OVD WAS USED. THE HANDPIECE WAS DISASSEMBLED AND INSPECTED AND NO ISSUES WERE OBSERVED, THE COMPLAINT ISSUE "LENS DAMAGED" WAS NOT IDENTIFIED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO A MANUFACTURING OR DESIGN ISSUE. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC., HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: NOT APPLICABLE, AS THERE WAS NO PATIENT CONTACT WITH THE DEVICE. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, THE LENS WAS NOT IMPLANTED. HENCE, NOT EXPLANTED. SECTION H3-OTHER (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 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 · 0

    IT WAS REPORTED THAT THE TORIC INTRAOCULAR LENS (IOL) WAS DISCOVERED TO BE DEFECTIVE WHILE LOADING. THE DEVICE HAD NO PATIENT CONTACT, AND THEY GOT A NEW LENS FOR THE CASE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179062 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. DIU150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PROVISC