台灣醫療器材
許可證資料查詢
MEDCHECK許可證索引
衛部醫器輸字
許可證編號
028273
輸入器材
醫療器材許可證 / 輸入器材

“博士倫”曙光白內障暨玻璃體視網膜手術儀

“Bausch& Lomb” Stellaris PC Vision Enhancement System

衛部醫器輸字第028273號
本站收錄狀態核准有效
有效日期2031 / 03 / 25
醫療器材級數第二等級

申請商為 博士倫股份有限公司,收錄 72 個 UDI 型號。 以下整理許可證、規格與製造廠資料,供核對產品身分使用。

許可證資料 依公開資料欄位整理

許可證字號
衛部醫器輸字第028273號
申請商
博士倫股份有限公司 (查看此申請商全部許可證)
統一編號
20921588
申請商地址
臺北市大安區敦化南路2段95號29樓
發證日期
2016 / 03 / 25
有效日期
2031 / 03 / 25
限制項目
輸 入
資料異動日期
2025 / 10 / 23

這類器材是什麼 晶體乳化儀,AI 輔助整理

晶體乳化儀是白內障手術用的設備,用超音波把混濁的水晶體震碎後吸出,再植入人工水晶體。它屬醫療器材,由醫師在手術室操作,病人不會自己買來用。

它在手術裡做什麼

白內障是水晶體變混濁,光線進不去。晶體乳化儀前端有一支細小的超音波探頭,從角膜上的小切口伸進眼內,把混濁的水晶體震碎、吸走,同時灌入液體維持眼內壓力。傷口小、恢復通常比傳統大切口手術快。

一台機器包含哪些東西

主機是重複使用的設備,真正接觸眼內的是手柄、管路、切割頭這類配件,多半是單次使用。本站收錄的 1,208 筆型號中,約 83% 標示為單次使用。

  • 主機:產生超音波能量、控制抽吸與灌流,放在手術室重複使用。
  • 手柄與超音波探頭:接觸眼內,多為單次使用或需滅菌。
  • 管路與配件包:灌流、抽吸用的管線,通常單次使用。
  • 玻璃體切割頭:合併玻璃體手術時使用的配件。

和雷射白內障手術差在哪

兩者都是處理白內障,但方式不同。飛秒雷射是用雷射先把水晶體切開、分割,後續把碎片吸出仍要靠晶體乳化儀;傳統作法則是全程用超音波探頭完成。哪一種適合,取決於白內障的硬度、眼睛其他狀況和醫師的判斷。

病人需要知道的事

這類器材的許可證全部是進口,本站收錄的 53 張裡,製造廠以美國最多,其次瑞士、德國、墨西哥。器材由醫療院所採購與維護,病人端不需要、也沒辦法自行確認單一手術用了哪一台。

  • 手術前可以問醫師:這台機器是否領有許可證、配件是否單次使用。
  • 有植入人工水晶體者,術後會拿到植入物標籤或證明,那是水晶體的資訊,不是乳化儀的。
  • 術後若出現劇烈疼痛、視力突然變差、眼睛紅腫,盡快回診。

常見問題

晶體乳化儀手術會痛嗎?

通常不會。手術多在局部麻醉下進行,點麻藥後眼睛有感覺但不太會痛。過程中可能覺得有水在沖、有光感。若真的不舒服,直接告訴手術團隊。

晶體乳化儀和飛秒雷射哪個比較好?

不一定,要看狀況。飛秒雷射負責前置的切割步驟,後段仍可能用到晶體乳化儀;傳統超音波乳化則是全程用探頭完成。白內障較硬、角膜內皮狀況、有無其他眼疾,都會影響選擇。

手術用的配件會重複使用嗎?

多數不會。本站收錄的型號中約 83% 標示單次使用,接觸眼內的管路、切割頭通常用過即丟。主機本身是可重複使用的設備,會依院所規範清潔與維護。

晶體乳化儀手術後多久可以恢復?

不一定,因人而異。多數人術後隔天視力就有改善,但完全穩定要數週。恢復速度和白內障硬度、有無其他眼疾、術後照護都有關係,實際情況請依醫師指示回診追蹤。

本段由 AI 依官方分類輔助整理,僅供認識器材之用,不構成醫療建議。使用前請以醫師指示與產品仿單為準。

UDI 標示 依 UDI 資料彙整

  • 單次使用是
  • 滅菌包裝未填
  • 天然橡膠(乳膠)不含
  • DEHP不含
  • 批號有
  • 序號有
  • 製造日期有
  • 有效期限有
  • 健保特材未填

這張許可證底下有多個型號時,只要其中一款有標示,就顯示為「是」或「有」。

效能與規格

效能
詳如中文仿單核定本
規格
Stellaris PC Vision Enhancement System
以下空白

製造廠

製造商
BAUSCH & LOMB INC.
國別
美國
廠址
3365 TREE COURT INDUSTRIAL BLVD ST. LOUIS MO 63122 U.S.A.
製造許可登錄編號
QSD7501

UDI 型號 共 72 筆

此許可證底下的 UDI 型號
基本 DI型號產品描述單次使用乳膠DEHP
0405893500006685783STThe irrigation aspiration handpieces, sterile for single use, currently include handpieces for aspiration and/or irrigation cortex removal, capsule polishing during cataract surgery (hereinafter referred to as I/A Handpieces), and handpieces for aspirating softened nuclei during cataract surgery (hereinafter called Zero Phaco Handpieces). The I/A Handpieces manufactured by B+L generally fall into three functional classes: irrigation only, aspiration only, and simultaneous irrigation and aspiration. The first two classes are referred as biaxial handpieces, whereas the third class is known as coaxial handpiece. 是 否 否
0405893500008085784STThe irrigation aspiration handpieces, sterile for single use, currently include handpieces for aspiration and/or irrigation cortex removal, capsule polishing during cataract surgery (hereinafter referred to as I/A Handpieces), and handpieces for aspirating softened nuclei during cataract surgery (hereinafter called Zero Phaco Handpieces). The I/A Handpieces manufactured by B+L generally fall into three functional classes: irrigation only, aspiration only, and simultaneous irrigation and aspiration. The first two classes are referred as biaxial handpieces, whereas the third class is known as coaxial handpiece. 是 否 否
0405893500011085786STThe irrigation aspiration handpieces, sterile for single use, currently include handpieces for aspiration and/or irrigation cortex removal, capsule polishing during cataract surgery (hereinafter referred to as I/A Handpieces), and handpieces for aspirating softened nuclei during cataract surgery (hereinafter called Zero Phaco Handpieces). The I/A Handpieces manufactured by B+L generally fall into three functional classes: irrigation only, aspiration only, and simultaneous irrigation and aspiration. The first two classes are referred as biaxial handpieces, whereas the third class is known as coaxial handpiece. 是 否 否
0405893500019685794STThe irrigation aspiration handpieces, sterile for single use, currently include handpieces for aspiration and/or irrigation cortex removal, capsule polishing during cataract surgery (hereinafter referred to as I/A Handpieces), and handpieces for aspirating softened nuclei during cataract surgery (hereinafter called Zero Phaco Handpieces). The I/A Handpieces manufactured by B+L generally fall into three functional classes: irrigation only, aspiration only, and simultaneous irrigation and aspiration. The first two classes are referred as biaxial handpieces, whereas the third class is known as coaxial handpiece. 是 否 否
0405893500020285795STThe irrigation aspiration handpieces, sterile for single use, currently include handpieces for aspiration and/or irrigation cortex removal, capsule polishing during cataract surgery (hereinafter referred to as I/A Handpieces), and handpieces for aspirating softened nuclei during cataract surgery (hereinafter called Zero Phaco Handpieces). The I/A Handpieces manufactured by B+L generally fall into three functional classes: irrigation only, aspiration only, and simultaneous irrigation and aspiration. The first two classes are referred as biaxial handpieces, whereas the third class is known as coaxial handpiece. 是 否 否
0405893500034985910SThe irrigation aspiration handpieces, sterile for single use, currently include handpieces for aspiration and/or irrigation cortex removal, capsule polishing during cataract surgery (hereinafter referred to as I/A Handpieces), and handpieces for aspirating softened nuclei during cataract surgery (hereinafter called Zero Phaco Handpieces). The I/A Handpieces manufactured by B+L generally fall into three functional classes: irrigation only, aspiration only, and simultaneous irrigation and aspiration. The first two classes are referred as biaxial handpieces, whereas the third class is known as coaxial handpiece. 是 否 否
0405893500036385910STThe irrigation aspiration handpieces, sterile for single use, currently include handpieces for aspiration and/or irrigation cortex removal, capsule polishing during cataract surgery (hereinafter referred to as I/A Handpieces), and handpieces for aspirating softened nuclei during cataract surgery (hereinafter called Zero Phaco Handpieces). The I/A Handpieces manufactured by B+L generally fall into three functional classes: irrigation only, aspiration only, and simultaneous irrigation and aspiration. The first two classes are referred as biaxial handpieces, whereas the third class is known as coaxial handpiece. 是 否 否
0405893500049385915SThe irrigation aspiration handpieces, sterile for single use, currently include handpieces for aspiration and/or irrigation cortex removal, capsule polishing during cataract surgery (hereinafter referred to as I/A Handpieces), and handpieces for aspirating softened nuclei during cataract surgery (hereinafter called Zero Phaco Handpieces). The I/A Handpieces manufactured by B+L generally fall into three functional classes: irrigation only, aspiration only, and simultaneous irrigation and aspiration. The first two classes are referred as biaxial handpieces, whereas the third class is known as coaxial handpiece. 是 否 否
0405893500051685915STThe irrigation aspiration handpieces, sterile for single use, currently include handpieces for aspiration and/or irrigation cortex removal, capsule polishing during cataract surgery (hereinafter referred to as I/A Handpieces), and handpieces for aspirating softened nuclei during cataract surgery (hereinafter called Zero Phaco Handpieces). The I/A Handpieces manufactured by B+L generally fall into three functional classes: irrigation only, aspiration only, and simultaneous irrigation and aspiration. The first two classes are referred as biaxial handpieces, whereas the third class is known as coaxial handpiece. 是 否 否
04058935000530E7924The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size. 否 否 否
04058935000547E7925The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size. 否 否 否
04058935000578E7928The Bipolar Eraser is a basic, pen-like design. The devices include a distal end, handpiece, and standard coupling means (proximal end) for connecting to bipolar probe to a bipolar coagulation unit. The tip at the distal end may be blunt or taper pointed and is available in different gauge size. 否 否 否

找的不是這個型號?

可改用包裝上的完整型號或許可證字號查詢。