U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
keratome, ac-powered - Product Code HNO
원인
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.
조치
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.
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.
제품 설명
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.