BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13906221 · Received March 25, 2022

    Report

    Report Number
    3012236936-2022-00738
    Event Type
    Injury
    Date Received
    March 25, 2022
    Report Date
    March 25, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE/DATE OF BIRTH: AGE RANGE BETWEEN 56.1±14.1 YEARS OF AGE. UNKNOWN/NOT PROVIDED. PER EU REGULATION 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. DATE OF EVENT: ARTICLE ACCEPTANCE DATE IS OCTOBER 1, 2021. MODEL NUMBER: PARTIALLY KNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN/NOT PROVIDED. EXPLANT DATE: UNKNOWN/NOT PROVIDED. THE INTRAOCULAR LENS (IOL) IS NOT RETURNING 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 IS NOT POSSIBLE AS NO SERIAL NUMBER INFORMATION WAS PROVIDED, THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN, AS SERIAL NUMBER WAS NOT PROVIDED. GAURISANKAR, Z.S., VAN RIJN, G.A., CHENG, Y.Y.Y., LUYTEN, G.P.M., BEENAKKER, J-W. M. (2021). TWO-YEAR RESULTS AFTER COMBINED PHACOEMULSIFICATION AND IRIS-FIXATED PHAKIC INTRAOCULAR LENS REMOVAL. GRAEFE'S ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY. 260(1), PP.1367¿1375. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON LITERATURE REVIEW. ARTICLE: TWO-YEAR RESULTS AFTER COMBINED PHACOEMULSIFICATION AND IRIS-FIXATED PHAKIC INTRAOCULAR LENS REMOVAL A RETROSPECTIVE STUDY WAS DONE TO DESCRIBE THE SURGICAL TECHNIQUE OF PERFORMING CATARACT SURGERY UNDERNEATH THE PHAKIC INTRAOCULAR LENS (PIOL) IN PATIENTS, PREVIOUSLY TREATED WITH AN (TORIC) ARTISAN OR ARTIFEX (OPHTEC BV) IRIS-FIXATED PHAKIC INTRAOCULAR LENS (IF-PIOL) AND PRESENT THE SAFETY AND VISUAL AND REFRACTIVE OUTCOMES OF THIS PROCEDURE. A TOTAL OF 59 EYES OF 40 PATIENTS UNDERWENT SINGLE INCISION TECHNIQUE (SIT) FOR COMBINED CATARACT SURGERY AND PIOL EXPLANTATION. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: MYOPIC EYES (N=50) AND HYPEROPIC EYES (N=9). THE IOL MODEL CHOSEN FOR IMPLANTATION INCLUDE THE FOLLOWING: TECNIS ZCB00, PCB00, OR ZA9003, AND SENSAR AR40 (JOHNSON &JOHNSON); ACRYSOF MA60MA AND SA60AT (ALCON); OR BIGBAG (CARL ZEISS MEDITEC AG). THE HEALON (JOHNSON & JOHNSON VISION SURGICAL) OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WAS ALSO USED DURING CATARACT SURGERY AND INJECTED INTO THE ANTERIOR CHAMBER TO SEPARATE THE PIOL FROM THE CRYSTALLINE LENS. IT WAS REPORTED THAT THE POSTOPERATIVE REFRACTIVE CYLINDER OF 17 EYES WERE NOT WITHIN =1.00 D. OVERALL POSTOPERATIVE ENDOTHELIAL CELL DENSITY (ECD) LOSS WAS -5.4 ± 11.8% AFTER 6 MONTHS AND -9.4±17.0% AFTER 6¿24 MONTHS WHICH WAS INTERPRETED TO BE AS A RESULT OF SURGICAL TRAUMA. THE POSTOPERATIVE SPHERICAL EQUIVALENT OF ONE EYE DEVIATED -1.78 D FROM TARGET REFRACTION IN WHICH THE PATIENT RECEIVED AN ADDITIONAL TORIC IF-PIOL 3 MONTHS AFTER SINGLE INCISION TECHNIQUE (SIT). CATARACT SURGERY WAS COMPLICATED BY A POSTERIOR CAPSULAR RUPTURE IN THREE EYES OF WHICH TWO EYES WITH VITREOUS LOSS. ONE MYOPIC PATIENT PRESENTED WITH A RHEGMATOGENOUS RETINAL DETACHMENT IN ONE EYE WITHIN 2 YEARS AFTER THE SIT PROCEDURE. IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN THE EYES INSERTED WITH TECNIS ZCB00, PCB00, OR ZA9003, SENSAR AR40 (JOHNSON & JOHNSON), OR THE OTHER PRODUCTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR MODEL ZA9003 ADVERSE EVENT. SEPARATE REPORTS ARE BEING SUBMITTED TO CAPTURE THE REPORTED ZCB00, PCB00, AND SENSAR AR40 ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127206 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention