Class 2 Device Recall Full Auto RefKeratometer

• Date Initiated by Firm: December 05, 2012
• Date Posted: May 25, 2013
• Recall Status: Terminated on September 20, 2013
• Recall Number: Z-1404-2013
• Recall Event ID: 65082
• Product Classification: Refractometer, ophthalmic - Product Code HKO
• Product: Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
• Code Information: Catalog Number 6937B002AA. All serial numbers from the first unit onward.
• FEI Number: 1000181430
• Recalling Firm/ Manufacturer: Canon Inc.; 30-2, Shimomaruko 3-chome,; Ohta-ku; Tokyo Japan
• Manufacturer Reason for Recall: Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.
• FDA Determined Cause: Software design
• Action: Canon initiated recall by sending letters on November 22, 2012 to all affected customers. The letter identified the affected product, problem, actions to be taken and contact information.
• Quantity in Commerce: 384 units
• Distribution: Worldwide Distribution - USA Nationwide and countries of: Australia, Japan, Korea, Singapore and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.