{"id":1430,"date":"2022-12-30T13:10:51","date_gmt":"2022-12-30T13:10:51","guid":{"rendered":"https:\/\/micromed.it\/warnings-pdms-site\/"},"modified":"2023-03-02T10:45:33","modified_gmt":"2023-03-02T10:45:33","slug":"warnings-pdms-site","status":"publish","type":"page","link":"https:\/\/micromed.it\/en\/warnings-pdms-site\/","title":{"rendered":"Warnings PDMS site"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|desktop&#8221; next_background_color=&#8221;#ffffff&#8221; admin_label=&#8221;Header&#8221; _builder_version=&#8221;4.18.0&#8243; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_direction=&#8221;130deg&#8221; background_color_gradient_stops=&#8221;#44b179 25%|#117e50 100%&#8221; background_color_gradient_start=&#8221;#8624E1&#8243; background_color_gradient_start_position=&#8221;25%&#8221; background_color_gradient_end=&#8221;#3607A6&#8243; background_image=&#8221;https:\/\/micromed.it\/wp-content\/uploads\/2022\/08\/Tavola-disegno-6.png&#8221; 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header_3_letter_spacing_last_edited=&#8221;on|tablet&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>PDMS<\/h2>\n<h1>WARNINGS<\/h1>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; admin_label=&#8221;Get Started&#8221; _builder_version=&#8221;4.16&#8243; custom_margin=&#8221;||-7px|||&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; saved_tabs=&#8221;all&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row use_custom_gutter=&#8221;on&#8221; gutter_width=&#8221;2&#8243; _builder_version=&#8221;4.16&#8243; max_width=&#8221;1700px&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;0px|||&#8221; use_custom_width=&#8221;on&#8221; custom_width_px=&#8221;1700px&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; custom_padding=&#8221;|||&#8221; global_colors_info=&#8221;{}&#8221; custom_padding__hover=&#8221;|||&#8221;][et_pb_image src=&#8221;https:\/\/micromed.it\/wp-content\/uploads\/2023\/02\/PDMS_boxes_NEW-1.png&#8221; title_text=&#8221;PDMS_boxes_NEW&#8221; align=&#8221;center&#8221; align_tablet=&#8221;center&#8221; align_phone=&#8221;center&#8221; align_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.19.5&#8243; width=&#8221;57%&#8221; max_width=&#8221;100%&#8221; custom_margin=&#8221;-6vw||||false|false&#8221; custom_margin_tablet=&#8221;0vw|||&#8221; custom_margin_phone=&#8221;&#8221; custom_margin_last_edited=&#8221;on|tablet&#8221; custom_padding=&#8221;||0px|||&#8221; animation_style=&#8221;fade&#8221; animation_direction=&#8221;left&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;19px|||||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2 style=\"text-align: center;\"><strong>General description of the device<\/strong><\/h2>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.20.0&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p style=\"text-align: justify;\">Medical devices in the <strong>PDMS<\/strong> family are on the market under various trade names, some of which bear the trademark of the distributor responsible for selling to end users.<\/p>\n<p style=\"text-align: justify;\"> <strong>PDMS<\/strong> is a viscous, high-density fluid intended to replace the vitreous humor, found in the eyeball, in surgeries in which the eyeball must be removed.<\/p>\n<p style=\"text-align: justify;\">In less complicated cases, the vitreous is not replaced, while at other times it is necessary to replace it with a so-called &#8220;vitreous substitute,&#8221; such as when there is a need to support the retina that might detach again or when there is a hemorrhagic risk or an excessive decrease in ocular pressure (hypotono) following the operation.<\/p>\n<p style=\"text-align: justify;\">After surgery, <strong>PDMS remains inside the eye for varying times from 3 to 6 months depending on the clinical situation and in any case for a period of more than 30 days<\/strong>.<\/p>\n<p style=\"text-align: justify;\"><strong>The device should only be used in sterile field by professionals.<\/strong><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; prev_background_color=&#8221;#ffffff&#8221; next_background_color=&#8221;rgba(56,186,131,0.72)&#8221; _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;rgba(56,186,131,0.72)&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;#00ba6c 0%|rgba(137,186,161,0.72) 100%&#8221; background_enable_image=&#8221;off&#8221; background_size=&#8221;initial&#8221; custom_padding=&#8221;88px|||||&#8221; top_divider_style=&#8221;wave2&#8243; bottom_divider_style=&#8221;curve2&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_icon font_icon=&#8221;&#xf14d;||fa||900&#8243; icon_color=&#8221;#000000&#8243; icon_width=&#8221;40px&#8221; _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; transform_rotate=&#8221;179deg|0deg|180deg&#8221; animation_style=&#8221;flip&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_icon][et_pb_text _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2 style=\"text-align: center;\"><span style=\"color: #000000;\"><strong>Contraindications<\/strong><\/span><\/h2>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; ul_text_color=&#8221;#000000&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: justify;\"><strong><span style=\"color: #000000;\">The main contraindications are for use by health care providers.<\/span><\/strong><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">Patients who have undergone PDMS surgery must strictly follow the instructions they were given at the hospital. They must also keep the implantable card and show it whenever they visit the hospital.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">The patient should definitely avoid exertion and pressure surges.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; next_background_color=&#8221;#ffffff&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;rgba(56,186,131,0.72)&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;#00ba6c 0%|#ffffff 42%&#8221; min_height=&#8221;417px&#8221; custom_margin=&#8221;||-2px||false|false&#8221; custom_padding=&#8221;74px||0px||false|false&#8221; top_divider_style=&#8221;wave2&#8243; top_divider_color=&#8221;#FFFFFF&#8221; top_divider_height=&#8221;55px&#8221; top_divider_flip=&#8221;vertical&#8221; bottom_divider_style=&#8221;wave2&#8243; bottom_divider_flip=&#8221;vertical&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.19.2&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_icon font_icon=&#8221;&#xe063;||divi||400&#8243; icon_color=&#8221;#000000&#8243; icon_width=&#8221;40px&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; transform_rotate=&#8221;179deg|0deg|180deg&#8221; animation_style=&#8221;flip&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_icon][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2 style=\"text-align: center;\"><span style=\"color: #000000;\"><strong>Risks and Warnings<\/strong><\/span><\/h2>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font_size=&#8221;16px&#8221; ol_text_color=&#8221;#000000&#8243; header_text_color=&#8221;#000000&#8243; custom_margin=&#8221;||32px|||&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">You should contact your doctor if you believe you are experiencing side effects related to the device or if you are concerned about the risks. The purpose of this document is not to replace a consultation with your physician.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">Follow the advice and precautions given to you at the hospital. Never stop treatment unless the surgeon says so; they help the operated eye heal better and prevent complications.<\/span><\/p>\n<ul>\n<li style=\"text-align: justify;\"><span style=\"color: #000000;\">Hold the head in the position indicated by the doctor.<\/span><\/li>\n<li style=\"text-align: justify;\"><span style=\"color: #000000;\">Do not rub the operated eye at all.<\/span><\/li>\n<li style=\"text-align: justify;\"><span style=\"color: #000000;\">Avoid putting any kind of pressure on the eye, such as while instilling medical eye drops or while washing your face.<\/span><\/li>\n<li style=\"text-align: justify;\"><span style=\"color: #000000;\">Avoid overexertion.<\/span><\/li>\n<li style=\"text-align: justify;\"><span style=\"color: #000000;\">Have all periodic checkups set by your doctor. Even after healing, the eye should be checked periodically by the ophthalmologist.<\/span><\/li>\n<li style=\"text-align: justify;\"><span style=\"color: #000000;\">Failure to take proper care, dressings, and postoperative checkups can jeopardize the success of the surgery.<\/span><\/li>\n<li style=\"text-align: justify;\"><span style=\"color: #000000;\">Always carry the implantable tag given to you and show it to the medical staff when you go to the hospital.<\/span><\/li>\n<li style=\"text-align: justify;\"><span style=\"color: #000000;\">See your doctor immediately if you experience symptoms other than those described by your doctor.<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][et_pb_image src=&#8221;https:\/\/micromed.it\/wp-content\/uploads\/2023\/01\/International_Implant_card_ITA.jpg&#8221; title_text=&#8221;International_Implant_card_ITA&#8221; align=&#8221;center&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; width=&#8221;85%&#8221; module_alignment=&#8221;center&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_image][et_pb_code _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;]<div class='w3eden'><!-- WPDM Link Template: Default Template -->\n\n<div class=\"link-template-default card mb-2\">\n    <div class=\"card-body\">\n        <div class=\"media\">\n            <div class=\"mr-3 img-48\"><img decoding=\"async\" class=\"wpdm_icon\" alt=\"Icon\" src=\"https:\/\/micromed.it\/wp-content\/plugins\/download-manager\/assets\/file-type-icons\/pdf.svg\" \/><\/div>\n            <div class=\"media-body\">\n                <h3 class=\"package-title\"><a href='https:\/\/micromed.it\/en\/download\/international-implant-card\/'>International Implant card<\/a><\/h3>\n                <div class=\"text-muted text-small\"><i class=\"fas fa-copy\"><\/i> 1 file(s) <i class=\"fas fa-hdd ml-3\"><\/i> 656.21 KB<\/div>\n            <\/div>\n            <div class=\"ml-3\">\n                <a class='wpdm-download-link download-on-click btn btn-primary ' rel='nofollow' href='#' data-downloadurl=\"https:\/\/micromed.it\/en\/download\/international-implant-card\/?wpdmdl=993&refresh=6a2d488c96c1d1781352588\">Download<\/a>\n            <\/div>\n        <\/div>\n    <\/div>\n<\/div>\n\n<\/div>[\/et_pb_code][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>PDMS WARNINGSGeneral description of the deviceMedical devices in the PDMS family are on the market under various trade names, some of which bear the trademark of the distributor responsible for selling to end users. 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