昊海生科(688366.SH)：子公司預裝式非球面人工晶狀體產品獲得醫療器械註冊批准
格隆匯11月1日丨昊海生科(688366.SH)公佈，公司全資子公司河南宇宙人工晶狀體研製有限公司(“河南宇宙”)於近日收到國家藥品監督管理局頒發的關於摺疊式人工晶狀體產品的2項《醫療器械註冊變更文件》，分別新增預裝式非球面人工晶狀體產品(P-PCF60/A)型號(“第一項變更”)，及適用於更廣泛患者尤其是高度近視和高度遠視患者的人工晶狀體產品(PCF60/L、PCF60/AL)型號(“第二項變更”)。
第一項變更，該產品為單件式後房人工晶狀體，可摺疊，襻形為改良C襻。人工晶狀體由羥乙基甲基丙烯酸酯/甲基丙烯酸甲酯共聚物(2-HEMA-co-MMA)材料製成，添加紫外吸收劑。光學設計：單焦，球面(PCF60)，非球面(PCF60/A)和非球面(P-PCF60/A)；P-PCF60/A為預裝式人工晶狀體，包含有預裝推注系統，人工晶狀體預裝在聚丙烯材質的人工晶狀體裝載架內，並浸泡在生理鹽溶液中。人工晶狀體滅菌方式為濕熱滅菌，預裝推注系統滅菌方式為環氧乙烷滅菌。
第二項變更，該產品為單件式後房人工晶狀體，可摺疊，襻形為改良 C襻。人工晶狀體由羥乙基甲基丙烯酸酯/甲基丙烯酸甲酯共聚物(2-HEMA-co-MMA)材料製成，添加紫外吸收劑。光學設計：單焦，球面(PCF60、PCF60/L)，非球面(PCF60/A、PCF60/AL)；光焦度-10.0D～37.0D(增量0.5D)；產品經濕熱滅菌。
新增 P-PCF60/A型號產品是國產首個獲批的預裝式親水非球面人工晶狀體，相比傳統非預裝式人工晶狀體，該產品有助於白內障手術操作，減少手術時間，便於手術標準化操作，手術過程中醫務人員不接觸人工晶狀體進而降低手術污染機率。
新增PCF60/L、PCF60/AL型號產品是我國國產獲批的光焦度範圍最大的人工晶狀體。該產品的增加，擴寬了公司人工晶狀體度數範圍和產品總直徑，更好滿足高度近視和高度遠視及囊袋鬆弛患者的需求，為手術醫生提供更寬範圍選擇，增大了產品臨牀使用場景。
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