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Class 2 Device Recall WaveLight FS 200 Femtosecond Laser System |
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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
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Product Classification |
keratome, ac-powered - Product Code HNO
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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/ Manufacturer |
Wavelight AG Industriegebiet Doellnitz 5 Pressath Germany
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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.
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FDA Determined Cause 2 |
Other |
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
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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.
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510(K) Database |
510(K)s with Product Code = HNO and Original Applicant = ALCON RESEARCH, LTD.
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