BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS EYHANCE IOL

    MDR report key: 11742233 · Received April 28, 2021

    Report

    Report Number
    2648035-2021-07644
    Event Type
    Injury
    Date Received
    April 28, 2021
    Report Date
    September 20, 2022
    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

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CODE 4581 PROVIDED ON THE INITIAL REPORT NEEDS TO BE EXPLAINED IN H10 TEXT. THIS REPORT IS SUBMITTED TO CORRECT THIS. SECTION H6: HEALTH EFFECT CLINICAL CODE: 4581 (TO CAPTURE POSTERIOR CAPSULE OPACIFICATION). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE OR DATE OF BIRTH, WEIGHT AND ETHNICITY: UNKNOWN/ NOT PROVIDED. DATE OF EVENT: UNKNOWN, NOT PROVIDED. SERIAL NUMBER : UNKNOWN/NOT PROVIDED. CATALOG NUMBER : UNKNOWN/NOT PROVIDED. EXPIRATION DATE: UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. UDI #: UDI # IS UNKNOWN AS PRODUCT SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE (2021 REPORTS) : IF IMPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. EXPLANT DATE (2021 REPORTS) : IF EXPLANTED; GIVE DATE: UNKNOWN/NOT PROVIDED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. DEVICE EVALUATION: THIS COMPLAINT WILL BE EVALUATED AS A MEDIUM-LEVEL INVESTIGATION PER AMO-04-S006 (COMPLAINT INVESTIGATION PROCEDURE, REVISION 21). NO PRODUCT RETURN NECESSARY. THE COMPLAINT ISSUE REPORTED COULD NOT BE VERIFIED AND NO PRODUCT DEFICIENCY COULD BE IDENTIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE REVIEWED AS SERIAL NUMBER WAS NOT AVAILABLE. UNABLE TO PERFORM THE COMPLAINT HISTORICAL REVIEW AS NO SERIAL NUMBER WAS PROVIDED. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY AND THE REPORTED ISSUE COULD NOT BE VERIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED. (B)(6).

    Description of Event or Problem · 1

    LITERATURE TITLE : "COMPARISON OF NEW MONOFOCAL INNOVATIVE AND STANDARD MONOFOCAL INTRAOCULAR LENS AFTER PHACOEMULSIFICATION". A RETROSPECTIVE COMPARATIVE STUDY WAS DONE TO EVALUATE THE EARLY FINDINGS OF NEW MONOFOCAL INTRAOCULAR LENS (IOL) TECNIS EYHANCE IN COMPARISON WITH STANDARD MONOFOCAL INTRAOCULAR LENS TECNIS 1-PIECE IN PATIENTS WHO UNDERWENT CATARACT SURGERY. THERE WERE SIXTY-FOUR EYES OF 32 PATIENTS INCLUDED IN THIS STUDY. THE TECNIS EYHANCE MODEL ICB00 IOL WERE BILATERALLY IMPLANTED IN 16 PATIENTS (GROUP 1), AND THE REMAINING 16 PATIENTS WERE IMPLANTED WITH TECNIS 1-PIECE MODEL ZCB00 IOL BILATERALLY (GROUP 2). AT POSTOPERATIVE 5 MONTHS, ONLY 1 PATIENT HAD A POSTERIOR CAPSULAR OPACIFICATION THAT NEEDED ND:YAG LASER CAPSULOTOMY. IT WAS NOT STATED WHETHER THE ADVERSE EVENT OCCURED WITH THE TECNIS EYHANCE MODEL OR THE TECNIS 1-PIECE MODEL. INCIDENCE OF PHOTIC PHENOMENA WAS REPORTED IN TECNIS EYHANCE IOL (GROUP 1): TYPE 1 HALO (DIFFUSE HALO RING) MILD (N=1), TYPE 1 HALO (DIFFUSE HALO RING) MODERATE (N=1), TYPE 2 HALO (HALO: STARBURST TYPE) MILD (N=3), TYPE 2 HALO (HALO: STARBURST TYPE) MODERATE (N=1), GLARE MILD (N=1), AND GLARE MODERATE (N=1). INCIDENCE OF PHOTIC PHENOMENA WAS REPORTED IN TECNIS 1-PIECE IOL (GROUP 2): TYPE 1 HALO (DIFFUSE HALO RING) MILD (N=2), TYPE 1 HALO (DIFFUSE HALO RING) MODERATE (N=1), TYPE 2 HALO (HALO: STARBURST TYPE) MILD (N=2), TYPE 2 HALO (HALO: STARBURST TYPE) MODERATE (N=2), AND GLARE MILD (N=1). IT WAS FOUND THAT, REGARDING TOLERANCE TO RESIDUAL REFRACTIVE ERRORS, TECNIS EYHANCE IOL WAS MORE FORGIVING TO UNEXPECTED RESULTS THAN TECNIS 1-PIECE IOL. THERE ARE NO INDICATIONS IN THE ARTICLE OF ANY INTERVENTIONS PROVIDED FOR THE OTHER EVENTS (EXCEPT FOR PCO WHICH REQUIRED YAG CAPSULOTOMY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634327 TECNIS EYHANCE IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ICB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention