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قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 045 10 11 000
Date submitted:
10/16/2011
Manufacturer:
Abbott Medical Optics Inc.
Device Type:
Optical, surgical, Femto second Laser Systems
Description:
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.
Remedy Action:
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.
Athorized Representative/Importer/Distributor:
Gulf Medical Co, Jeddah, (02) 6512828
Report Source:
NCMDR
Source Ref. Number:
3FC00475551CD
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Abbott Medical Optics Inc.pdf
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