BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 17511533 · Received August 11, 2023

    Report

    Report Number
    3012236936-2023-02054
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    July 3, 2023
    Report Date
    January 4, 2024
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655478
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER WERE EVALUATED. ALL FOUR PHOTOGRAPHS DISPLAYED A LENS ALLEGING TO BE THE COMPLAINT LENS. A PARTICLE ON THE HAPTIC THAT EXTENDS PAST THE EDGE OF THE HAPTIC CAN BE OBSERVED. DUE TO THE QUALITY OF THE PHOTOGRAPHS, THE NATURE AND ORIGIN OF THE PARTICLE COULD NOT BE DETERMINED AND NO FURTHER EVALUATION COULD BE PERFORMED. THE COMPLAINT ISSUES OF COSMETIC ISSUES, DELIVERY ISSUE, IOL TORN, AND LENS DAMAGED WERE NOT CONFIRMED DURING PRODUCT EVALUATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION AND CORRECTED DATA: THIS FILING IS TO UPDATE THE SECTIONS BELOW AS PER NEW INFORMATION RECEIVED POST FOLLOW-UP WITH THE ACCOUNT. SECTION B3 - DATE OF EVENT: JULY 03, 2023. SECTION E1 - (B)(6). SECTION E3 - OCCUPATION: PHYSICIAN ALL PERTINENT INFORMATION AVAILABLE. TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES. SECTION D9 - DATE RETURNED TO MANUFACTURER: NOVEMBER 14, 2023. SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO THE MANUFACTURING SITE FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE COMPLAINT HANDPIECE WAS RECEIVED WITH THE PLUNGER ROD ADVANCED TO THE CARTRIDGE TIP. THE LENS MODULE WAS INSPECTED AND NO MARKS THAT WOULD INDICATE THAT THE PLUNGER ROD ADVANCED INCORRECTLY COULD BE IDENTIFIED. THE CARTRIDGE WAS OBSERVED TO HAVE STRESS MARKS IN THE CARTRIDGE TIP; THESE MARKS ARE CONSISTENT WITH A USED CARTRIDGE. THERE WAS VISCOELASTIC RESIDUE DISTRIBUTED THROUGHOUT THE LENGTH OF THE CARTRIDGE, SUGGESTING THAT AN APPROPRIATE AMOUNT OF OPHTHALMIC VISCOSURGICAL DEVICE (OVD)/ BALANCED SALT SOLUTION (BSS) WAS USED. THE LENS WAS RECEIVED TAPED TO THE HANDPIECE; THE LENS WAS REMOVED AND CLEANED, REVEALING THAT THERE WERE SCRATCHES AT THE EDGE OF THE LENS OPTIC. THE HANDPIECE WAS DISASSEMBLED AND NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLIANT ISSUE COULD BE IDENTIFIED. PHOTOGRAPHS PROVIDED BY THE CUSTOMER WERE EVALUATED. ALL FOUR PHOTOS DISPLAY A LENS ALLEGING TO BE THE COMPLAINT LENS. A FILM ON THE HAPTIC EXTENDING PAST THE EDGE OF THE HAPTIC CAN BE OBSERVED. DUE TO THE QUALITY OF THE PHOTOGRAPH, THE NATURE AND ORIGIN OF THE PARTICLE COULD NOT BE DETERMINED. THE COMPLAINT ISSUE COSMETIC ISSUES 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. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. THE COMPLAINT ISSUES DELIVERY ISSUE, IOL TORN, AND LENS DAMAGED WERE 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. THEREFORE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SECTION A2, A4 AND A5: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION B3 - DATE OF EVENT: DATE UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE LENS WAS NOT IMPLANTED. SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 - OTHER (81): THE INTRAOCULAR LENS (IOL) WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 AND POSSIBLE PRODUCT RETURN AND EVALUATION, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EYEHANCE INTRAOCULAR LENS (IOL) WAS FAULTY. DURING THE LENS PREPARATION, IT WAS OBSERVED THAT THE OPTIC WAS WEIRDLY BENT, CAUSING THE PLASTIC ROD TO PUSH A PIECE OF THE LENS OPTIC OUT. ACCOUNT ALSO INDICATED THAT AFTER REMOVING THE LENS FROM ITS INSERTER, MARKS WERE FOUND ON THE OPTIC. THE BACK UP LENS WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868278 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655478

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown