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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-13-10-24-627
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Ophthalmic Viscosurgical Device (OVD)
الأجهزة المتأثرة
Products: Visthesia 1.5% Visthesia intra 1.5% Visthesia 1.0% Z Hyalcoat Z Hyalin Z Hyalin Plus Please refer to the attachment for Batch numbers and Product Code.
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
It has been identified a hole defect within a single blister OVD product during routine shelf-life confirmatory testing (post product release).
الإجراء التصحيحي
• Please check every blister of the product batches you have received detailed in the attachment before use. • This is in line with the instruction in the IFU “ not to be used if sterile packaging has been damaged”. • In the event a hole defect has been identified in the blister, the product should not be used. • Customer should return it to GMC for disposal and replacement.
المرفقات
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