BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSAR IOL

    MDR report key: 17373566 · Received July 21, 2023

    Report

    Report Number
    3012236936-2023-01887
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    February 13, 2023
    Report Date
    July 21, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2: MEAN AGE 36.8 ± 9.4 (18¿60) YEARS. SECTION A3: 31 FEMALE (56.4%) AND 24 MALE (43.6%) . SECTION B3: DATE OF EVENT: EXACT DATES NOT PROVIDED. ARTICLE PUBLISHED DATE IS FEBRUARY 13, 2023. SECTION H3-OTHER (81): THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE SERIAL NUMBER FOR THIS DEVICE IS NOT AVAILABLE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SECTION H4: DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION H6 -HEALTH EFFECT - CLINICAL CODE 4581: POSTERIOR CAPSULE OPACIFICATION. CITATION: ÖZDAMAR EROL, Y.; ÖZDEMIR YALÇINSOY, K.; ÖZDAL,P.; THE OUTCOMES OF CATARACT SURGERY IN EYES WITH FUCHS UVEITIS; JOURNAL OF OPHTHALMIC INFLAMMATION AND INFECTION; HTTPS://DOI.ORG/10.1186/S12348-022-00320-3. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: THE OUTCOMES OF CATARACT SURGERY IN EYES WITH FUCHS UVEITIS. A RETROSPECTIVE STUDY WAS DONE TO EVALUATE CLINICAL RESULTS IN EYES UNDERGOING PHACOEMULSIFICATION INTRAOCULAR LENS (IOL) IMPLANTATION DUE TO FUCHS UVEITIS (FU) RELATED COMPLICATED CATARACT. A TOTAL OF 56 EYES OF 55 SUBJECTS WITH FU UNDERWENT PHACOEMULSIFICATION INTRAOCULAR LENS (IOL) IMPLANTATION USING THE WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM (AMO). THE SUBJECTS WERE DIVIDED INTO THREE GROUPS: A HYDROPHILIC SAF6125 IOL (OPTIMA FOLD) WAS IMPLANTED IN 10 EYES, A HYDROPHOBIC SN60AT IOL (ALCON) IN 24 EYES, AND A HYDROPHOBIC AAB00 IOL (ABBOTT) IN 22 EYES. POSTOPERATIVE COMPLICATIONS INCLUDE 6 EYES HAVING INCREASED INTRAOCULAR PRESSURE THAT WAS CONTROLLED BY TOPICAL 2% DORZOLOMID-0.5% TIMOLOL MALEATE IN THE FIRST WEEK AFTER THE PHACOEMULSIFICATION SURGERY, CYSTOID MACULAR EDEMA (CME) WHICH DEVELOPED IN 2 EYES WHICH REGRESSED IN THE FIRST MONTH OF FOLLOW-UP WITH POSTERIOR SUBTENON TRIAMCINOLONE 40 MG INJECTION IN 1 EYE AND INTRAVITREAL DEXAMETHASONE IMPLANT IN 1 EYE. RHEGMATOGENOUS RETINAL DETACHMENT (RD) DEVELOPED IN 1 EYE IN THE SECOND-YEAR FOLLOW-UP. IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN THE EYES IMPLANTED WITH HYDROPHOBIC AAB00 IOL (ABBOTT) OR THE OTHER PRODUCTS. POSTERIOR CAPSULE OPACIFICATION (PCO) DEVELOPMENT WAS OBSERVED IN 13 EYES IMPLANTED WITH THE HYDROPHOBIC AAB00 IOL IN WHICH YAG (YTTRIUM ALUMINIUM GARNET) LASER CAPSULOTOMY WAS PERFORMED IN 11 EYES AS TREATMENT. GIANT CELL (GC) DEPOSITS ON THE IOL WERE DETECTED IN 3 EYES IN THE AAB00 GROUP. THIS REPORT IS FOR THE EVENTS RELATED TO THE AAB00 LENSES, A SEPARATE REPORT IS BEING SUBMITTED FOR THE EVENTS RELATED TO THE WHITESTAR SIGNATURE SYSTEM. A COPY OF AN EXTRACT FROM THE ARTICLE IS PROVIDED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975137 SENSAR IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. AAB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention