BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 11743209 · Received April 29, 2021

    Report

    Report Number
    2648035-2021-07663
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    May 13, 2020
    Report Date
    September 20, 2022
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    MJP
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION H6: AS PART OF AN INTERNAL REVIEW OF OUR MDRS IT WAS IDENTIFIED THAT THE CLINICAL CODE 4582 PROVIDED ON THE INITIAL REPORT SUBMITTED NEEDS TO BE CORRECTED. THE CORRECT HEALTH EFFECT - CLINICAL CODES WOULD BE (2140) GLARE AND (2138) UNEXPECTED POST-OP REFRACTION. TIS REPORT IS SUBMITTED TO CORRECT THESE. FIELDS BELOW UPDATED: H6: HEALTH EFFECT-CLINICAL CODE: 2140 (TO CAPTURE GLARE, PERSISTENT) AND 2138 (TO CAPTURE UNEXPECTED POST-OP REFRACTION). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH (MONTHS): AGES ARE 21-90. SEX/GENDER: MALE AND FEMALE. WEIGHT & ETHNICITY: INFORMATION UNKNOWN, NOT PROVIDED. DATE OF EVENT: EXACT DATES NOT PROVIDED, ARTICLE ACCEPTANCE DATE IS MAY 13, 2020. MODEL NUMBER: UNKNOWN, INFORMATION NOT PROVIDED. CATALOG NUMBER: A COMPLETE CATALOG # 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: A COMPLETE UDI NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IMPLANT DATE: UNKNOWN, INFORMATION NOT PROVIDED. EXPLANT DATE: NOT APPLICABLE, AS LENS WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN DEVICE EVALUATION: THE PRODUCT TESTING COULD NOT BE PERFORMED AS THE PRODUCT WAS NOT RETURNED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION: THE MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE SERIAL NUMBER OF THE COMPLAINT PRODUCT IS UNKNOWN. SINCE THE SERIAL NUMBER IS UNKNOWN, THE COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. SINCE THE SAMPLE OF THE COMPLAINT PRODUCT WAS NOT RETURNED, AND SERIAL NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO DETERMINE A MALFUNCTION AND/OR PRODUCT QUALITY DEFICIENCY. AN ATTEMPT HAS BEEN MADE TO OBTAIN MISSING INFORMATION; HOWEVER, TO DATE, NO RESPONSE HAS BEEN RECEIVED. CITATION: YANG, J.J., QIN,Y.Z., QIN, L., AND LI, J.M. (2020). COMPARISON OF THE CLINICAL EFFICACY OF ACRYSOF IQ AND TECNIS TORIC INTRAOCULAR LENSES: A REAL-WORLD STUDY. EXPERIMENTAL AND THERAPEUTIC MEDICINE. 20(25): PP 1-9. 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: COMPARISON OF THE CLINICAL EFFICACY OF ACRYSOF R IQ AND TECNIS R TORIC INTRAOCULAR LENSES: A REAL-WORLD STUDY. A RETROSPECTIVE COHORT STUDY WAS DONE TO COMPARE THE CLINICAL EFFICACY OF ACRYSOF IQ WITH TECNIS TORIC IOL IMPLANTATION, AND TO PROVIDE A CLINICAL BASIS ON SELECTING AN APPROPRIATE TORIC IOL BEFORE CATARACT SURGERY FOR PATIENTS WITH CORNEAL ASTIGMATISM. A TOTAL OF 44 EYES OF 30 PATIENTS WITH CATARACT AND CORNEAL ASTIGMATISM UNDERWENT PHACOEMULSIFICATION WITH TORIC IOL IMPLANTATION. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: ACRYSOF IQ TORIC IOL SN6AT3-T7 GROUP (N=26 EYES; ALCON) AND THE TECNIS TORIC IOL ZCT225-400 GROUP (N=18 EYES; JOHNSON & JOHNSON VISION). THE MISALIGNMENT WAS WITHIN ±5° IN 32 OF 44 EYES AND WITHIN ±10° IN 41 OF 44 EYES; HOWEVER, IT IS NOT CLEAR HOW MANY EYES IMPLANTED WITH TECNIS DEVELOPED A MISALIGNMENT OF ±5° AND ±10°. ONE (N=1 EYE) TECNIS TORIC IOL MISALIGNMENT WAS FOUND TO HAVE ROTATED BY -18.0° AT 1 WEEK AFTER THE OPERATION BUT REPOSITIONING WAS NOT PERFORMED BECAUSE THE PATIENT EXPRESSED GOOD SATISFACTION AND REFUSED REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641397 TECNIS IOL LENS, INTRAOCULAR, TORIC OPTICS MJP AMO PUERTO RICO MFG. INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown