Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Exc
FDA device recall Z-1695-2008 · posted 2008-08-20 · Terminated
Recall details
- Recalling firm
- VISX INCORPORATED, A SUBSIDIARY OF AMO INC
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LZS
- Quantity affected
- 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,
- Date initiated
- 2006-11-17
- Date posted
- 2008-08-20
- Date terminated
- 2010-06-08
- Location
- Santa Clara, CA
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