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U.S. Department of Health and Human Services

Class 2 Device Recall AMO WaveScan WaveFront System v3.65

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  Class 2 Device Recall AMO WaveScan WaveFront System v3.65 see related information
Date Initiated by Firm November 17, 2006
Date Posted August 20, 2008
Recall Status1 Terminated 3 on June 08, 2010
Recall Number Z-1695-2008
Recall Event ID 47824
PMA Number P930016/S16 P930016S023 
Product Classification Excimer Laser System - Product Code LZS
Product Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones.
Code Information All systems with software version 3.65 and earlier: Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478.
Recalling Firm/
Manufacturer		 VISX INCORPORATED, A SUBSIDIARY OF AMO INC
3400 Central Expy
Santa Clara CA 95051-0703
For Additional Information Contact
714-247-8656
Manufacturer Reason
for Recall		 Firm became aware of a significant overcorrection in one eye of a patient who had received a wavefront-guided LASIK treatment at a facility in Germany. The probability of a recurrence of this error was determined to be extremely remote. To ensure that this type of incident will not happen again, a software update was developed.
FDA Determined
Cause 2		 Software design
Action VISX issued a notification letter on November 27, 2006, to all distributors and direct accounts. The letter informed the recipients that they were performing a field correction in the form of a mandatory upgrade on all VISX WaveScan WaveFront Systems and Offline Programming Modules to correct an issue. The field upgrade should be made by February 16, 2007. A Dear Doctor letter was also issued instructing surgeons to upgrade all Offline Programming Modules using an enclosed CD.
Quantity in Commerce 1310 units
Distribution Class 2 Recall - Worldwide Distribution: USA, Venezuela, Colombia, Italy, Saudi Arabia, Kuwait, Egypt, UAE, Jordan, Lebanon, Australia, Canada, France, Germany, India, Ireland, Japan, Sweden, Vietnam, Czech Republic, Slovak Republic, Bulgaria, Philippines, South Korea, Turkey, UK, Portugal, Spain, Argentina, Israel, Cyprus, India, Mexico, Greece, Singapore, Chile, Poland, Brazil, China, Thailand, Taiwan, Hong Kong and Russia.
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.
PMA Database PMAs with Product Code = LZS and Original Applicant = AMO Manufacturing USA, LLC
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