BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17819191 · Received September 26, 2023

    Report

    Report Number
    3012236936-2023-02447
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    August 31, 2023
    Report Date
    October 22, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474636163
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/CORRECTED DATA: THE FOLLOWING ADDITIONAL INFORMATION WAS INADVERTENTLY NOT CAPTURED IN THE INITIAL MDR REPORT; THEREFORE, IT HAS BEEN CAPTURED IN THIS SUPPLEMENTAL MDR REPORT ACCORDINGLY: SECTION B5: ADDITIONAL INFORMATION RECEIVED INDICATED BENT TOP HAPTIC, BUT THE HAPTIC WAS NOT DETACHED. THE LENS WAS FOR THE PATIENT'S LEFT EYE. ANOTHER JOHNSON & JOHNSON LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED AS A REPLACEMENT LENS. THE ISSUE WAS OBSERVED PRIOR TO INSERTION. IT WAS INDICATED THAT OPHTHALMIC VISCOELASTIC DEVICE (OVD) AND BALANCED SALT SOLUTION (BSS) WERE USED. THE BSS WAS AT ROOM TEMPERATURE AND THE OVD WAS ALSO ALLOWED TO ACCLIMATIZE FULLY TO THE OPERATING ROOM (OR) TEMPRETURE. AFTER INSERTER PREP, THERE WERE NO DELAYS IN THE SURGERY BEFORE AN ATTEMPT WAS MADE TO ADVANCE THE LENS. THE LENS MOVED A LITTLE WHEN THEY TRIED TO ADVANCE IT AND THEN DID STICK, THAT THE LENS GOT STUCK AND ROTATED WHILE ADVANCING. IT WAS CONFIRMED THAT THE LENS WAS POSITIONED CLOSER TO THE TIP OF THE CARTRIDGE THAN NORMAL. SECTION A2: DATE OF BIRTH: APR 24, 1957 SECTION A3: GENDER: FEMALE SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES SECTION D9: RETURNED TO MANUFACTURER ON: OCT 2, 2023 SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES SECTION E1: TITLE (E.G., MR., MS.): DOCTOR SECTION E1: FIRST/GIVEN NAME: (B)(6) SECTION E1: MIDDLE NAME: (B)(6) SECTION E1: LAST NAME: (B)(6) SECTION E2: HEALTH PROFESSIONAL? YES SECTION E3: OCCUPATION: PHYSICIAN DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION UNDER MAGNIFICATION REVEALED THAT THE COMPLAINT HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD FULLY ADVANCED. THE COMPLAINT CARTRIDGE WAS RECEIVED WITH THE LENS STUCK INSIDE OF THE CARTRIDGE. THE CARTRIDGE TIP COULD BE OBSERVED TO BE DAMAGED, IN A WAY CONSISTENT WITH A CARTRIDGE THAT WAS DAMAGED DURING SHIPPING. FURTHER INSPECTION OF THE CARTRIDGE REVEALED THAT THERE WAS NOT VISCOELASTIC RESIDUE DISPERSED THROUGHOUT THE LENGTH OF THE CARTRIDGE, SUGGESTING THAT AN INADEQUATE AMOUNT OF OVD/BSS MAY HAVE CONTRIBUTED TO THE COMPLAINT ISSUE. THE HANDPIECE WAS DISASSEMBLED, AND THE ASSEMBLY WAS INSPECTED, NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE COULD BE IDENTIFIED. THE LENS WAS REMOVED FROM THE CARTRIDGE AND CLEANED, REVEALING THAT THE LENS WAS DAMAGED, IN A WAY CONSISTENT WITH A LENS THAT WAS FOLDED INSIDE OF THE CARTRIDGE. THE HAPTIC COULD NOT BE OBSERVED TO BE DAMAGED. THE COMPLAINT ISSUE "HAPTIC DAMAGED" WAS NOT CONFIRMED DURING PRODUCT EVALUATION. THE OTHER OBSERVED ISSUES DURING THE PRODUCT EVALUATION COULD NOT BE CONFIRMED TO BE RELATED TO THE MANUFACTURING OR DESIGN PROCESS. CONCLUSION: BASED ON THE INVESTIGATION, NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED, AND THE REPORTED COMPLAINT WAS NOT VERIFIED. 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

    THE SURGERY CENTER REPORTED BENT HAPTIC WITH A MONOFOCAL INTRAOCULAR LENS (IOL). THERE WAS NO PATIENT CONTACT REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019652 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DCB00 05050474636163

    Patients

    Seq Age Sex Outcome Treatment
    1 Female