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U.S. Department of Health and Human Services

Class 2 Device Recall AMO brand WaveScan WaveFront System

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  Class 2 Device Recall AMO brand WaveScan WaveFront System see related information
Date Initiated by Firm July 13, 2010
Date Posted February 18, 2011
Recall Status1 Terminated 3 on June 22, 2012
Recall Number Z-1374-2011
Recall Event ID 56394
PMA Number P930016S016 
Product Classification Excimer laser system - Product Code LZS
Product AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67,
Part Number: 0070-1531, Catalog Numbers:
0070-1664,0070-1649,0070-1654: Version 3.67
0070-1721: Version 3.671
0070-1662: Version 3.67, US version;
0070-1668; IVersion 3.67 International version

Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA

The WaveScan WaveFront System is a class III accessory device used in conjunction with the VISX¿ STAR S4 and STAR S4 IRTM Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan WaveFront System is a diagnostic instrument intended for the automated measurement, analysis, and recording of refractive errors of the eye. The WaveScan System software uses the diagnostic data of the eye's refractive errors and wavefront aberrations to calculate the target treatment shape and then generates the commands for the VISX STAR laser to create the target shape on the cornea.
Code Information All units of these Catalog Numbers. Part Number: 0070-1531, Catalog Numbers:  0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.671  0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 nternational version  
Recalling Firm/
AMO Manufacturing USA, LLC
510 Cottonwood Dr
Milpitas CA 95035-7403
For Additional Information Contact Sandra Selvaggi
Manufacturer Reason
for Recall
The failure to comply with Minimum System Requirements, increased system errors could result, and a miscreated treatment table (incorrect LASIK refractive treatment) could result.
FDA Determined
Cause 2
Software design
Action Abbott Medical Optics, Inc. sent an Urgent Medical Device Field Correction letter to all affected customers starting July 15, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to take the following actions: Surgeons were instructed to complete the facsimile attachment to acknowledge receipt of the notification letter and fax to 714-247-4530. For those using the affected product a 3.68 OPM disc must be requested by e-mailing a request to OPM@pacful.com. For any questions please contact AMO Technical Service Representatiave at 1-877-266-4543.
Distribution Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britian, Greece, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Netherland, New Zealand, Peru, Philippines, Portugal, Russia, Russia Federation, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Taiwan, ThailandChina, India, South Korea, Singapore, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela, and Vietnam.
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