Jan

2008

Visx Wavescan System Class II

Company: Visx, Inc
Date of Enforcement Report 1/30/2008
Class:ll

PRODUCT
Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478, Recall # Z-0365-2008

REASON
Erroneous Treatment Calculations – Two software caused errors; in combination, in the WaveScan System Software, will result in an erroneous treatment calculation (overcorrection) in patients. (1) Installation of software for a certain brand of computer (Dedicated Computing LLC) can cause a software registry setting for an algorithm that identifies image reflection to be erroneously set in the “off” position upon installation on these specific computers, and (2) Software error in the WaveScan System application produces erroneous treatment calculations.

RECALLING FIRM/MANUFACTURER
Visx, Inc., Santa Clara, CA, by letter on May 30, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
329 systems

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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Visx Wavescan System Class II

Amy Sellers

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