28

Aug

2008

Cl Il Visx Incorporated

0

Company: Visx Incorporated
Date of Enforcement Report 8/27/2008
Class:ll

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. Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478; Recall # Z-1695-2008

REASON
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 determine to be extremely remote, however to prevent re-occurrence of this type of incident a software update was developed.

RECALLING FIRM/MANUFACTURER
Visx Incorporated, a subsidiary of AMO, Inc., Santa Clara, CA, by letter on November 27, 2006. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
1,310 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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