BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 21049144 · Received December 31, 2024

    Report

    Report Number
    3012236936-2024-000341
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    November 14, 2024
    Report Date
    June 20, 2025
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474655126
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE FOLLOWING FIELD IS BEING UPDATED PER NEW INFORMATION RECEIVED: SECTION B5 - DESCRIBE EVENT OR PROBLEM: ACCOUNT INDICATED THAT THE EXPLANTED LENS HAD BEEN SENT TO AN EXTERNAL OPTICAL LAB WHERE IT WAS CONFIRMED TO HAVE A 15-DIOPTER MISALIGNMENT WITH ITS LABELED POWER. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION B5 - DESCRIBE EVENT OR PROBLEM: IT WAS ALSO REPORTED THAT THE LENS WAS EXPLANTED ON (B)(6) 2024, AND SUCCESSFULLY REPLACED WITH A DCB00 MODEL LENS OF +5.5 DIOPTER DURING AN UNEVENTFUL SURGERY. THEREFORE, THE FOLLOWING FIELD IS BEING UPDATED: SECTION D6B. IF EXPLANTED, GIVE DATE: (B)(6) 2024 SECTION D9 - DEVICE AVAILABLE FOR EVALUATION? YES SECTION D9 - DATE RETURNED TO MANUFACTURER: 02-JUN-2025 SECTION H3 - DEVICE EVALUATED BY MANUFACTURER? YES DEVICE EVALUATION: VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SUSPECT PRODUCT. THE LENS WAS RECEIVED WHOLE AND COVERED IN LINT AND DEBRIS FROM THE GAUZE IN THE CONTAINER IT WAS RECEIVED IN. THE LENS WAS CLEANED AND INSPECTED REVEALING NO ISSUES THAT COULD CAUSE OR CONTRIBUTE TO THE COMPLAINT ISSUE REPORTED. THE COMPLAINT LENS WAS FORWARDED TO THE MANUFACTURING SITE FOR RE-MEASUREMENT. THE LENS WAS MEASURED RESULTING IN A 21.73 DIOPTER. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS NOT RELEASED WITHIN DIOPTER SPECIFICATION. FURTHER INVESTIGATION WAS INITIATED TO EVALUATE THE CAUSE. 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 D6A - IMPLANT DATE: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED SECTION D6B - EXPLANT DATE: UNKNOWN, AS INFORMATION WAS REQUESTED BUT NOT PROVIDED SECTION E1 - TELEPHONE NUMBER: (B)(6). SECTION H3 : 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. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY IN BOTH EYES, A REFRACTIVE SURPRISE WAS NOTED, INITIALLY WITHOUT TREATMENT. THROUGH FOLLOW-UP WE LEARNED THAT THE ISSUE WAS SPECIFIC TO THE RIGHT EYE. THE PHYSICIAN REVISED THE ORIGINAL CALCULATIONS AND REPLACED THE IOL, DETERMINING THAT THE DIOPTRIC POWER WAS NOT +6.0 AS EXPECTED BUT APPROXIMATELY +18.00, BASED ON CURVATURE MEASUREMENTS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116369 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474655126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other