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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 045 10 11 000
Abbott Medical Optics Inc.
Optical, surgical, Femto second Laser Systems
Optical, surgical, Laser
Medical Device Identifier:
Models 2, 3 and iFS
Reason of Field Safety Corrective Action:
AMO has identified a minor discrepancy between the user-set depth of corneal tissue incisions and the actual depth of those incisions by way of in vitro testing.
AMO will be contacting you in the near future to schedule a visit by a Field Service Representative who will adjust your AMO Femto second Laser to correct this cut depth discrepancy. User Action attached.
Gulf Medical Co, Jeddah, (02) 6512828
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Abbott Medical Optics Inc.pdf
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.