تسجيل الدخول
تسجيل جديد
السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-21-09-25-1062
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
CONSTELLATION® ULTRAVIT® (10K) and HYPERVIT® (20K) probes
الأجهزة المتأثرة
Product Reference: CONSTELLATION® ULTRAVIT® 10K CONSTELLATION® HYPERVIT® 20K Intended for use with the CONSTELLATION® Vision System and packs or kits containing those probes. Please refer to the attachment for details.
الممثل المعتمد
Alcon Pharmaceuticals Ltd Branch
سبب المشكلة
There is potential for ULTRAVIT and HYPERVIT to unexpectedly fail to actuate and cut during use.
الإجراء التصحيحي
To mitigate the potential risk associated with unexpected cut stoppage during surgery, Alcon is advising customers to take the following precautions: 1. Strictly adhere to the Instructions for Use (IFU) regarding limitations, including maximum use time and single-use only. 2. When using a probe model identified as within the scope of the Medical Device Correction: a. Reduce the actuation rate to no more than 5000 actuations per minute. b. Adjust other related console settings as needed to accommodate the reduced cutting/actuation rate. c. If a reduction of cutting capability or failure to actuate is observed during the surgical procedure, stop immediately. Take all necessary surgical precautions to remove the probe and replace it with an unused probe. Alcon will notify customers regarding replacement inventory as soon as adequate inventory of new, non-affected probes is available. Manufacturer's Action: Instructions and Removal.
المرفقات
عودة للقائمة
