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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-30-08-24-578
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Various Ophthalmic Knives and Valved Entry Systems
الأجهزة المتأثرة
25+ TOTALPLUS Vit Pak- 10000CPM Bevel Wide Valved; Product # 8065752438; Product Lot Number(s) 16C9RF, 16DDFU, 16HE6F 25+ TOTALPLUS Comb Proc Pak- 10000CPM Bevel Wide Valved/0.9mm; Product # 8065752451, Product Lot Number(s) 16C9PY 25+ TOTALPLUS Vit Pak - 20000CPM Bevel Wide Valved; Product # 8065830077, Product Lot Number(s) 16HE70
الممثل المعتمد
Alcon Pharmaceuticals Ltd
سبب المشكلة
There is a potential for some knives and trocar entry systems within specific lots to not meet sharpness expectations.
الإجراء التصحيحي
Alcon provided the following actions to be taken by the customer / user: • If you received sterile standalone knives or trocar entry system, we are asking that you dispose of the affected ophthalmic knife/trocar entry system and use a replacement. Alcon is sending sufficient replacement quantities to cover your estimated remaining impacted inventory. • If you received a Vitrectomy/Combined Procedure Pak ® with affected trocar entry system lot numbers, we are asking that, upon opening your Vitrectomy/Combined Procedure Pak for surgical use, you remove and dispose of the affected trocar entry system and use a replacement trocar entry system. Alcon is sending sufficient replacement quantities to cover your estimated remaining impacted inventory. Refer to "Actions to be taken by the Customer / User" in the attachment for more details.
المرفقات
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