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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 077 07 11 000
Date submitted: 7/20/2011
Manufacturer:Abbott Medical Optics
Device Type:Excimer Laser System
Description: Lasers, Excimer, Ophthalmic
Medical Device Identifier:STAR S4 IR Excimer Laser System, Software Versions 5.00 – 5.22.
Reason of Field Safety Corrective Action:Abbott Medical Optics Inc. (AMO) is providing this Advisory Notice to all customers who use the AMO STAR S4 IR Excimer Laser System to make you aware of a discrepancy with pupil centroid shift compensation
Remedy Action:Create a separate patient file for each eye on the WaveScan WaveFront System. This action achieves the full benefits of IR which includes compensation for pupil centroid shift and compensation for cyclorotation in both eyes. As always, caution must be exercised to ensure treatment is applied to the correct eye. To treat a patient who does not have a separate patient file created for each eye, do not engage the IR function in the STAR S4 IR Excimer Laser System before commencing treatment.
Athorized Representative/Importer/Distributor:Alhaya medical co. Riyadh (01) 4655075
Report Source:NCMDR
Source Ref. Number:79BEFDF4D13F9
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Excimer Laser System.pdf