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U.S. Department of Health and Human Services

Class 2 Device Recall WaveLight FS 200 Femtosecond Laser System

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  Class 2 Device Recall WaveLight FS 200 Femtosecond Laser System see related information
Date Initiated by Firm April 18, 2011
Date Posted May 25, 2011
Recall Status1 Terminated 3 on September 23, 2011
Recall Number Z-2292-2011
Recall Event ID 58601
510(K)Number K101006  
Product Classification keratome, ac-powered - Product Code HNO
Product WaveLight FS200 Femtosecond Laser System

Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2.

The WaveLight FS 200 Laser System is an ophthalmic surgical laser indicated for use in refractive surgery for LASIK flap cutting, lamellar and perforating keratoplasty, and intrastromal surgery for implants.
Code Information Alcon Product Code 8065990714 WaveLight Model 1025 Software Version: Version Blue, Service Pack 2
Recalling Firm/
Wavelight AG
Industriegebiet Doellnitz 5
Pressath Germany
Manufacturer Reason
for Recall
The software calculating the patterns were found to has a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue.
FDA Determined
Cause 2
Action WaveLight AG sent an URGENT MEDICAL DEVICE CORRECTION letter April 18, 2011 to the affected customers. The letter identified the product, problem and the action to be taken by the customer. The letter advised the customers to discontinue keratoplasty cuts with the WaveLight FS200 until the new version can be installed. Alcon will contact you to schedule a visit of a service engineer at your site, to disable the keratoplasty function in your device, until a new software version can be installed to fix this problem. If you have experienced a product problem or adverse event related to this medical device correction, please contact Alcon Medical Safety at 1-800-561-6466, option 3. Customers were requested to complete the attached reply form to acknowledge receipt of this notification and fax it to ( 817) 916-9087.
Quantity in Commerce 55 units
Distribution Worldwide Distribution - USA including states of TX, KS, NC, CA, FL, OH, SC, MD, VA and NY and countries of Switzerland, Germany, Greece, United Kingdom, Ireland, Spain, Italy, Australia, India, Malaysia, France, Finland, Saudi Arabia, Czech Republic, Poland, China and South Korea and Iran.
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.
510(K) Database 510(K)s with Product Code = HNO and Original Applicant = ALCON RESEARCH, LTD.