Advanced Medical Optics (AMO), VISX WaveScan WaveFront System (software). Part Number 0070-1478. Advanced Medical Optics, Santa Clara, CA 95051.
FDA Recall Z-0365-2008 · Posted 2008-01-23
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Recalling FirmVisx Inc
Recall StatusTerminated
Product CodeLZS
Date Initiated2007-05-30
Date Terminated2008-04-17
Product Quantity196 systems are affected in the U.S. and 133 outside of the U.S.
Reason for Recall
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
Firm Action
AMO sent an Action Required notification on May 30, 2007, to AMO Certified Physicians. The letter included a CD software update (0070-1721) to be installed by users that provided correct registry parameter settings. Upon completion of installation, a confirmation form will print out. Customers are requested to fax back confirmation to AMO (408-773-7055).
Root Cause
Software design
Distribution Pattern
Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO,MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,OR,PA, SC, TN, TX, UT, VA, WA, WI, and WV and countries of Canada and Mexico.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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