{"id":1398,"date":"2022-09-05T15:12:39","date_gmt":"2022-09-05T15:12:39","guid":{"rendered":"https:\/\/micromed.it\/pdms-warnings\/"},"modified":"2023-03-02T10:45:32","modified_gmt":"2023-03-02T10:45:32","slug":"pdms-warnings","status":"publish","type":"page","link":"https:\/\/micromed.it\/en\/pdms-warnings\/","title":{"rendered":"PDMS Warnings"},"content":{"rendered":"

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PDMS<\/h2>\n

WARNINGS<\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Get Started” _builder_version=”4.16″ custom_margin=”||-7px|||” custom_padding=”0px||0px||false|false” saved_tabs=”all” global_colors_info=”{}”][et_pb_row use_custom_gutter=”on” gutter_width=”2″ _builder_version=”4.16″ max_width=”1700px” custom_margin=”|||” custom_padding=”0px|||” use_custom_width=”on” custom_width_px=”1700px” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/micromed.it\/wp-content\/uploads\/2023\/02\/PDMS_boxes_NEW-1.png” title_text=”PDMS_boxes_NEW” align=”center” align_tablet=”center” align_phone=”center” align_last_edited=”on|desktop” _builder_version=”4.19.5″ width=”57%” max_width=”100%” custom_margin=”-6vw||||false|false” custom_margin_tablet=”0vw|||” custom_margin_phone=”” custom_margin_last_edited=”on|tablet” custom_padding=”||0px|||” animation_style=”fade” animation_direction=”left” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.19.2″ _module_preset=”default” custom_margin=”-20px|auto||auto||” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.19.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.19.2″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

General description of the device<\/strong><\/h2>\n

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Medical devices in the Silicone Oil family are on the market under different trade names: PDMS vial, PDMS glass syringe, PDMS refill syringe, PDMS dispenser syringe<\/strong>.<\/span><\/p>\n

<\/span>Devices in the PDMS family consist of 4 primary packaging types: glass vial, glass syringe, plastic syringe with dispenser, and plastic refill syringe.<\/span><\/p>\n

Silicone oil is a long-term vitreous substitute injected into the vitreous chamber following vitreous removal in order to promote retinal adhesion.<\/span><\/p>\n

Following the operation, the silicone oil is not absorbed and therefore remains in the eye for a variable time generally exceeding 30 days after which it is removed by surgery.<\/span><\/p>\n

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The device is contained in a tyvek bag along with accessories. The silicone oil contained in vial must be poured into an infusion system already supplied to the operating room, in the case of pre-filled syringes this is ready to use and can be equipped with an infusion system, as in the case of dispenser syringes.<\/span><\/p>\n

The specific ways of using each configuration are given in the package insert.<\/span><\/p>\n

Both silicone oil and accessories are supplied sterile in all 4 configurations. All medical devices have, however, the same indication of use, the same principle of operation, are used for the same purposes.<\/span><\/p>\n

The choice in using one viscosity and\/or configuration over another is part of the clinical experience and preference of the surgeon performing the operation.<\/span><\/p>\n

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Directions for use.<\/strong><\/span><\/h2>\n

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Silicone oil is a high-viscosity fluid intended to replace vitreous humor in vitrectomy surgeries. <\/span><\/p>\n

Removal of the vitreous body is necessary in many situations. <\/span><\/p>\n

Silicone oil is not absorbed locally, so after about 3-6 months<\/strong>, removal of silicone oil by subsequent surgery is necessary. <\/span><\/p>\n

The device should only be used in sterile field by professionals.<\/span><\/strong><\/p>\n

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Contraindications<\/strong><\/span><\/h2>\n

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The contraindications listed in this document are the same as those included within the package insert.<\/span><\/p>\n