Volver al buscador
FDAFDA · Alimentos y medicamentos·N.º oficial Z-0334-2014

Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

Publicado el 27 de noviembre de 2013 · Inicio del retiro: 23 de octubre de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

The user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0" in the internal lens database of the IOLMaster. The correct value is -2.420. This could lead to the implantation of lens with a wrong diopter value.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Carl Zeiss Meditec, Inc.
Distribuidor
Nationwide distribution.
Lote
Serial Numbers: 817123 1038929 1038930 1044483 1044485 1044487 1044488 1044489 1044490 1045639 1046055 1046056 1046057 1046343 1046344 1046345 1046353 1046355 1046364 1046373 1046374 1046376 1046377 1046378 1046380 1046381 1046488 1046489 1046500 1046509 1046514 1046516 1046523 1047089 1047090 1047091 1047092 1047093 1047101 1047107 1047111 1047266 1047267 1047268 1047269 1047270 1047271 1047272 1047273 1047275 1047279 1047282 1047283 1047284 1047485 1047486 1047494 1047498 1047499 1047507 1047512 1047513 1047518 1047519 1047520 1047521 1047522 1047523 1047524 1047914 1047921 1047922 1047923 1047924 1047933 1047934 1047935 1047936 1047938 1048579 1048580 1048581 1048582 1048583 1048584 1048585 1048587 1048589 1049601 1049602 1049603 1049604 1049605 1049607 1049608 1049609 1049610 1049611 1049620 1049621 1049622 1050560 1050561 1050562 1050563 1050564 1050566 1050567 1050568 1050569 1050748 1050749 1050751 1050752 1050753 1050754 1050755 1050756 1050757 1050758 1050759 1050760 1050761 1050762 1050763 1051518 1051519 1051520 1051521 1051522 1051523 1051524 1051525 1051526 1051527 1051528 1051529 1051530 1051531 1051533 1051534 1051536 1051538 1051550 1051551 1051552 1051553 1051554 1051860 1051861 1051872 1051873 1051874 1051875 1051876 1051877 1051879 1052512 1052513 1052515 1052516 1052517 1052518 1052519 1052520 1052527 1052528 1052529 1052917 1052918 1052919 1052920 1052944 1052945 1052946 1052947 1052948 1052949 1052951 1052952 1052955 1053181 1053183 1053186 1053187 1053188 1053189 1053190 1053191 1053193 1053194 1053206 1053207 1053208 1053209 1053210 1053211 1053212 1053213 1053554 1053555 1053556 1053558 1053561 1053562 1053563 1053564 1053566 1053567 1053568 1053571 1053573 1053574 1053841 1053847 1054330 1054332 1054338 1054339 1054341 1054342 1054343 1054344 1054347 1054351 1054360 1054362 1054363 1054365 1054366 1054367 1054369 1055236 1055244 1055245 1055246 1055247 1055248 1055249 1055251 1055263 1055266 1055267 1055268 1055949 1055950 1055951 1055952 1055953 1055954 1056018 1056019 1056020 1056021 1056023 1056025 1056026 1056027 1056028 1056451 1056452 1056453 1056454 1056455 1056456 1056457 1057114 1057126 1057127 1057128 1057130 1057131 1057163 1057164 1057165 1057166 1057168 1057177 1057178 1057179 1057181 1057182 1057183 1057188 1057445 1057450 1057451 1057453 1057455 1057460 1058039 1058041 1058042 1058043 1058044 1058045 1058046 1058047 1058050 1058051 1058052 1058585 1058592 1058606 1058607 1058608 1058609 1058610 1058611 1058612 1058613 1058614 1058615 1058618 1058619 1058620 1058621 1058624 1058625 1058627 1058628 1058629 1058649 1058650 1058651 1058652 1058661 1058662 1058663 1059225 1059226 1059227 1059228 1059229 1059230 1059233 1059235 1059236 1059237 1059238 1059869 1059870 1059874 1059875 1059876 1059877 1059878 1059880 1059881 1059885 1059888 1060586 1060591 1060592 1060595 1060596 1060597 1060598 1060599 1060602 1060604 1060605 1060606 1060608 1060609 1060610 1060611 1060612 1060613 1060614 1060615 1060616 1060620 1061181 1061182 1061183 1061184 1061185 1061187 1061188 1061189 1061190 1061191 1061192 1061196 1061202 1061203 1061204 1061205 1061206 1061207 1061208 1061209 1061211 1061212 1061214 1061215 1061217 1061219 1062545 1062546 1062547 1062548 1062549 1062550 1062551 1062553 1062554 1062555 1062556 1062557 1062558 1062559 1062560 1062783 1063470 1063471 1063472 1063473 1063474 1063475 1063476 1063479 1063480 1063481 1063499 1063500 1063501 1063503 1064061 1064070 1064071 1064072 1064073 1064074 1064075 1064076 1064077 1064078 1064086 1064087 1064089 106409
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

¿Vendes productos como este?

Recalert vigila todo tu catálogo contra retiros como este, automáticamente.

Empezar gratis — sin tarjeta