BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS IOL

    MDR report key: 13944741 · Received March 29, 2022

    Report

    Report Number
    3012236936-2022-00785
    Event Type
    Injury
    Date Received
    March 29, 2022
    Report Date
    March 29, 2022
    Manufacturer
    AMO MANUFACTURING NETHERLANDS
    Product Code
    POE
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE/DATE OF BIRTH: AGE RANGE BETWEEN 55¿64, 65¿75, AND 76+, MEAN AGE WAS 71.1 YEARS (SD:7.9) OLD; NOT SPECIFIED IF GROUPED WITH JOHNSON & JOHNSON IMPLANT. SEX/GENDER: 4028 (41.1%) MALES AND 5770 (58.9%) FEMALES; NOT SPECIFIED IF GROUPED WITH JOHNSON & JOHNSON IMPLANT. WEIGHT: UNKNOWN/NOT PROVIDED. ETHNICITY: RACE/ETHNICITY: 7255 (74.0%) WHITE, 795 (8.1%) HISPANIC, 831 (8.5%) AFRICAN AMERICAN, 422 (4.3%) ASIAN, 271 (2.8%) OTHER, AND 224 (2.3%) UNKNOWN; NOT SPECIFIED IF GROUPED WITH JOHNSON & JOHNSON IMPLANT. DATE OF EVENT: 8/20/2021 (DATE ARTICLE PUBLISHED.) CATALOG NUMBER: A COMPLETE CATALOG NUMBER IS UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. SERIAL NUMBER: UNKNOWN/ASKED BUT UNAVAILABLE. EXPIRATION DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. UNIQUE IDENTIFIER (UDI) NUMBER: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. IF IMPLANTED, GIVE DATE: UNKNOWN, INFORMATION WAS REQUESTED BUT NOT PROVIDED. IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THERE WAS NO INDICATION THE LENS WAS EXPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN, AS THE SERIAL NUMBER WAS NOT PROVIDED. (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THERE WAS NO SERIAL NUMBER REPORTED FOR THIS DEVICE; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. PATNAIK, J.L., CHRISTOPHER, K.L., PEDLER, M.G., SHIEH, B., PETRASH, C.C., WAGNER, B.D., MANDAVA, N., LYNCH, A.M., PALESTINE, A.G., PETRASH, J.M. (2021). THE PROTECTIVE EFFECT OF METFORMIN USE ON EARLY ND:YAG LASER CAPSULOTOMY. INVESTIGATIVE OPHTHALMOLOGY & VISUAL SCIENCE. 62(10):24 DOI: HTTPS://DOI.ORG/10.1167/IOVS.62.10.24. AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION WAS CONDUCTED, HOWEVER THERE IS NO ADDITIONAL INFORMATION AVAILABLE. 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 PROTECTIVE EFFECT OF METFORMIN USE ON EARLY ND:YAG LASER CAPSULOTOMY A RETROSPECTIVE COHORT STUDY WAS DONE TO DETERMINE THE EFFECT OF METFORMIN ON EARLY ND:YAG LASER TREATMENT FOR POSTERIOR CAPSULE OPACIFICATION (PCO) AND TO EXPLORE A MOLECULAR MECHANISM TO EXPLAIN A POSSIBLE PROTECTIVE EFFECT OF METFORMIN AGAINST PCO. A TOTAL OF 9798 EYES UNDERWENT PHACOEMULSIFICATION AND THE MONOFOCALS IMPLANTED INCLUDE ZCB00 (JOHNSON & JOHNSON), SN60WF/SA60WF (ALCON), OR MX60 (BAUSCH AND LOMB). MOST MONOFOCAL TORICS IMPLANTED ARE SA6ATX (ALCON) OR ZCTXXX (JOHNSON & JOHNSON). THE MAJORITY OF LENSES CATEGORIZED FOR THE ANALYSIS AS MULTIFOCAL INCLUDED ZXR00, ZXTXX, ZKB00, OR ZMB00 (JOHNSON & JOHNSON). THE OVERALL RATE OF ND:YAG LASER CAPSULOTOMY WAS 13.1% (N = 1283 EYES) PRESUMABLY DUE TO PCO. IT IS NOT CLEAR IF THIS COMPLICATION OCCURRED IN THE EYES IMPLANTED WITH ZCB00, ZCTXXX, ZXR00, ZXTXX, ZKB00, OR ZMB00 (JOHNSON & JOHNSON) OR THE OTHER PRODUCTS. THIS REPORT IS FOR MODEL ZXR00. SEPARATE REPORTS ARE BEING SUBMITTED TO CAPTURE ADDITIONAL MODEL NUMBERS ZCTXXX, ZCB00, ZXTXX, ZKB00, AND ZMB00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698465 TECNIS IOL EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS POE AMO MANUFACTURING NETHERLANDS ZXR00

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention