BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL IOL

    MDR report key: 11737756 · Received April 28, 2021

    Report

    Report Number
    2648035-2021-07681
    Event Type
    Injury
    Date Received
    April 28, 2021
    Report Date
    April 28, 2021
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: INFORMATION UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. BEST ESTIMATE OF DATE OF EVENT IS BETWEEN 2007-2016. CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, AS INFORMATION WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: ONLY YEAR OF 2007 WAS PROVIDED. IF EXPLANTED, GIVE DATE: ONLY YEAR OF 2016 WAS PROVIDED. DEVICE EVALUATED BY MANUFACTURER: 81 (OTHER): THE INTRAOCULAR LENS (IOL) IS NOT RETURNING FOR EVALUATION AS IT IS DISCARDED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, LABELING, 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. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. WERNER, L., MOULIN, T., WALLAS, K., BALENDIRAN, V., SHUMWAY, C., ELLIS, N., MAMALIS, N. (2019). SURFACE DEPOSITS MIMICKING CALCIFICATION ON A HYDROPHOBIC ACRYLIC INTRAOCULAR LENS. JOURNAL OF CATARACT & REFRACTIVE SURGERY 45(7), PP. 1036-1039. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: SURFACE DEPOSITS MIMICKING CALCIFICATION ON A HYDROPHOBIC ACRYLIC INTRAOCULAR LENS. A CASE REPORT WAS DONE TO DESCRIBE A PATIENT WHO HAD HYDROPHOBIC ACRYLIC INTRAOCULAR LENSES (IOLS) IMPLANTED AND EXHIBITED CLINICAL POSTOPERATIVE FINDINGS THAT WERE SUSPICIOUS FOR CALCIFICATION UNDER SLIT LAMP EVALUATION. IN 2007, A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT UNEVENTFUL CATARACT SURGERY IN BOTH EYES AND IMPLANTED WITH 3-PIECE SILICONE IOLS TECNIS Z9002 (ABBOTT MEDICAL OPTICS, INC.). IN 2016, THE PATIENT WAS REFERRED FOR POSTERIOR CAPSULE OPACIFICATION (PCO) WITH SYMPTOMS OF DIFFICULTY IN READING, AND CORRECTED DISTANCE VISUAL ACUITY (CDVA) OF 20/50 IN THE RIGHT EYE AND 20/40 IN THE LEFT EYE. SLITLAMP EVALUATION REVEALED CLOUDINESS PREDOMINANTLY ON THE POSTERIOR ASPECT OF BOTH IOLS, AS WELL AS THE BEGINNING OF PCO IN BOTH EYES. WHEN CALCIFICATION WAS SUSPECTED, THE IOLS WERE EXPLANTED AND EXCHANGED WITH A 3-PIECE HYDROPHOBIC ACRYLIC IOL TECNIS Z9003 (ABBOTT MEDICAL OPTICS, INC.) IN BOTH EYES. THROUGH FOLLOW-UP, IT IS BELIEVED THE ORIGINAL SURGERY WAS 2007. THE OPERATIVE (OP) NOTES NO LONGER AVAILABLE. THEREFORE, THE SERIAL NUMBER IS UNKNOWN. THERE WERE NO SURGICAL COMPLICATIONS WITH THE SURGERY. THE CAPSULE WAS INTACT. THE LENS WAS MOST LIKELY DISCARDED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR MODEL Z9002 ADVERSE EVENT IN THE LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED TO CAPTURE THE REPORTED Z9002 ADVERSE EVENT IN THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636189 TECNIS CL IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention