BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 16440594 · Received February 24, 2023

    Report

    Report Number
    3012236936-2023-00470
    Event Type
    Injury
    Date Received
    February 24, 2023
    Report Date
    February 24, 2023
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE/DATE OF BIRTH (YEARS): MEAN AGES ARE 58.1 ± 13.6 SEX/GENDER: (MALE: FEMALE): 131:33 INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS 27 APR 2022. A COMPLETE CATALOG NUMBER IS UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UDI NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS LENS REMAINS IMPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. HEALTH EFFECT - CLINICAL CODE 4581: NO CODE AVAILABLE (DEVICE DISLOCATION) DEVICE EVALUATION PRODUCT TESTING COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED (THE LENS REMAINS IMPLANTED). THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED, AND THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED, AND COMPLAINT HISTORY WERE NOT REVIEWED SINCE THE SERIAL NUMBER IS UNKNOWN. 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS RECEIVED BASED ON A LITERATURE REVIEW: ARTICLE: CLINICAL CHARACTERISTICS OF RECURRENT INTRAOCULAR LENS DISLOCATION AFTER SCLERAL-FIXATED SUTURED INTRAOCULAR LENS AND LONG-TERM OUTCOMES OF INTRAOCULAR LENS RE-FIXATION A RETROSPECTIVE STUDY WAS DONE TO INVESTIGATE THE CLINICAL CHARACTERISTICS OF PATIENTS WITH RECURRENT INTRAOCULAR LENS (IOL) DISLOCATION AFTER SCLERAL-FIXATED SUTURED IOL IMPLANTATION AND EVALUATE THE LONG-TERM OUTCOMES OF SCLERAL RE-FIXATION OF IOL. A TOTAL OF 176 EYES OF 164 PATIENTS UNDERWENT SCLERAL-FIXATED SUTURED IOL SURGERY FOR IOL DISLOCATION. THE PROCEDURE WAS PERFORMED USING EITHER THE FOLLOWING IOLS: RAYNER 920H (RAYNER INTRAOCULAR LENSES LTD), TECNIS ZCB00 (JOHNSON & JOHNSON VISION), CZ70BD (ALCON LABORATORIES, INC.), SENSAR AR40E (PHARAMACIA AND UPJOHN LLC), OR ARTIS PL E (CRISTALENS INDUSTRIES). IT WAS REPORTED THAT 26 EYES EXPERIENCED RE-DISLOCATION (RE-DISLOCATED GROUP) AND HAD TO UNDERGO A SECOND SCLERAL-FIXATED SUTURED IOL OPERATION. THREE OF THESE CASES REQUIRED A THIRD OPERATION AFTER THE SECOND SCLERAL-SUTURED IOL IMPLANTATION (N=3). THE CAUSE FOR THE RE-DISLOCATION WERE THE FOLLOWING: LUXATION OR SUBLUXATION OF THE IOL (9.5% OF ALL LUXATIONS AND SUBLUXATIONS OF THE IOL CASES), COMPLICATED CATARACT SURGERY (41.7% OF THIS SUBGROUP), AND LUXATION OR SUBLUXATION OF THE CRYSTALLINE LENS (20% OF THIS SUBGROUP). THE MEAN ENDOTHELIAL CELL COUNT (ECC) VALUES BEFORE AND 6 MONTHS AFTER SURGERY WERE 2224.5 ± 567.9 AND 1635.6 ± 747.8 AND 2099.9 ± 606.5 AND 1482.7 ± 677.1 IN THE NON-RE-DISLOCATED (N=150 EYES) AND RE-DISLOCATED GROUPS (N=26 EYES), RESPECTIVELY. POST-OPERATIVE COMPLICATIONS IN THE NON-RE-DISLOCATED GROUP INCLUDE INTRAOCULAR PRESSURE ELEVATION (N=37) IN WHICH 31 WERE TREATED WITH ANTIGLAUCOMA MEDICATION ONLY AND 4 UNDERWENT GLAUCOMA SURGERY, CYSTOID MACULAR EDEMA (N=25), UVEITIS (N=12), VITREOUS HEMORRHAGE (N=2), BULLOUS KERATOPATHY (N=4) IN WHICH 4 UNDERWENT DESCEMET STRIPPING ENDOTHELIAL KERATOPLASTY (DSEK), SUTURE EXPOSURE (N=2), RETINAL DETACHMENT (N=1), AND ASTIGMATISM=5 DIOPTER (N=5). POST-OPERATIVE COMPLICATIONS IN THE RE-DISLOCATED GROUP (N=150) INCLUDE INTRAOCULAR PRESSURE ELEVATION (N=10) IN WHICH 8 WERE TREATED WITH ANTIGLAUCOMA MEDICATION ONLY AND 1 UNDERWENT GLAUCOMA SURGERY, CYSTOID MACULAR EDEMA (N=4), UVEITIS (N=3), VITREOUS HEMORRHAGE (N=3), BULLOUS KERATOPATHY (N=2) IN WHICH 1 UNDERWENT DESCEMET STRIPPING ENDOTHELIAL KERATOPLASTY (DESK), SUTURE EXPOSURE (N=1), RETINAL DETACHMENT (N=1), AND ASTIGMATISM=5 DIOPTER (N=1). IT IS NOT CLEAR IF THESE COMPLICATIONS OCCURRED IN THE EYES IMPLANTED WITH TECHNICS ZCB00 (JOHNSON & JOHNSON VISION) OR THE OTHER PRODUCTS. OTHER JNJ PRODUCTS WERE MENTIONED BUT NO COMPLAINTS WERE REPORTED AGAINST THEM. A COPY OF THE ARTICLE IS PROVIDED WITH THIS REPORT. CITATION: YEJI KIM, EUN YOUNG CHOI, CHRISTOPHER SEUNGKYU LEE, SUNG SOO KIM, SUK HO BYEON, CLINICAL CHARACTERISTICS OF RECURRENT INTRAOCULAR LENS DISLOCATION AFTER SCLERAL-FIXATED SUTURED INTRAOCULAR LENS AND LONG-TERM OUTCOMES OF INTRAOCULAR LENS RE-FIXATION, (2022), GRAEFE'S ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY; 260:3267¿3273

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857838 TECNIS IOL INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention