Events

Rappel de Device Recall WaveScan WaveFront System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Visx Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    39353
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0365-2008
  • Date de mise en oeuvre de l'événement
    2007-05-30
  • Date de publication de l'événement
    2008-01-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=55273
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Excimer Laser System - Product Code LZS
  • Cause
    Erroneous treatment calculations - two software caused errors; in combination, in the wavescan system software, will result in an erroneous treatment calculation (overcorrection) in patients. (1) installation of software for a certain brand of computer (dedicated computing llc) can cause a software registry setting for an algorithm that identifies image reflection to be erroneously set in the "off.
  • Action
    AMO sent an Action Required notification on May 30, 2007, to AMO Certified Physicians. The letter included a CD software update (0070-1721) to be installed by users that provided correct registry parameter settings. Upon completion of installation, a confirmation form will print out. Customers are requested to fax back confirmation to AMO (408-773-7055).

Device

Device Recall WaveScan WaveFront System
  • Modèle / numéro de série
    System Serial Numbers affected include: 75447, 75448, 76086, 75389, 70170, 76092, 76004, 76020, 76070, 76128, 75391, 75413, 75416, 75417, 75423, 75441, 75442, 76043, 76046, 76048, 76082, 76091, 76121, 76144, 76147, 75419, 76122, 75257, 75385, 75386, 76003, 76022, 76111, 76018, 75390, 76050, 76098, 75420, 76071, 76075, 76114, 75411, 75425, 76123, 76124, 76136, 75384, 75421, 76002, 76023, 75449, 76084, 76119, 76085, 76033, 76036, 76083, 76076, 76052, 76089, 76067, 75444, 75450, 76047, 76099, 76146, 76026, 75424, 76095, 75410, 76106, 75392, 75409, 75428, 75452, 76025, 76032, 76045, 76053, 76097, 70213, 70256, 70316, 70776, 75358, 75418, 75430, 75431, 75432, 76042, 76044, 76049, 76051, 76077, 76078, 76108, 76109, 76116, 76126, 76141, 76035, 76087, 76112, 75398, 76115, 76013, 76120, 76057, 75387, 76021, 76125, 76127, 76130, 76135, 75422, 76069, 75415, 76110, 76137, 76161, 76163, 70419, 70869, 75403, 76096, 76142, 70304, 70160, 70250, 70666, 70753, 70890, 75028, 75402, 75405, 75426, 75429, 75436, 76007, 76027, 76029, 76031, 76037, 76065, 76068, 76073, 78074, 76079, 76103, 76117, 76139, 76140, 76143, 76150, 76151, 76153, 76155, 76156, 76157, 76159, 76160,76162, 70272, 70280, 70297, 70706, 70872, 75297, 75359, 75404, 76059, 76061, 76063, 76081, 76149, 75397, 75399, 70541, 70774, 70904, 75412, 75437, 76017, 70043, 70394, 75401, 75439, 76066, 76080, 76088, 76148, 76058, 76090, 70271, 70353, 70398, 70409, 70734, 76006, 76009, 76028, 76154, 76158, 76145, 70855, 76038, 76062, 75433, 70864, 75394, 75434, 76138, 71704, 70217, 70485, 70491, 70690, 75281, 76104, 75406, 75414, 75427, 76015, 70286, 70440, 70476, 70765, 70882, 75400, 75446, 76005, 75388, 76024, 76039, 76129, 70588, 70603, 75445, 76040, 70597, 70175, 70178, 76094, 70759, 70336, 70637, 75230, 76093, 76105, 75121, 76019, 76056, 76060, 70333, 70341, 70365, 70379, 70428, 75113, 76001, 76054, 70691, 75109, 76107, 70299, 75234, 70554, 70653, 75236, 76011, 76152, 70474, 70495, 70542, 75440, 76101, 76118, 76113, 75435, 76012, 70031, 70032, 70036, 70092, 70227, 70580, 70608, 70721, 75172, 75395, 75408, 75443, 75451, 76016, 76030, 76034, 76072, 76100, 76064, 70080, 70221, 70283, 75328, 75396, 75438, 75407, 70159, 70241, 70350, 76008, 76010, 76014, 70650, 70732, 76055, 76102, 70457, and 76041
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO,MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,OR,PA, SC, TN, TX, UT, VA, WA, WI, and WV and countries of Canada and Mexico.
  • Description du dispositif
    Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.
  • Manufacturer
    Visx Inc

Manufacturer

Visx Inc
  • Adresse du fabricant
    Visx Inc, 3400 Central Expressway, Santa Clara CA 95051
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA