AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-

FDA device recall Z-1374-2011 · posted 2011-02-18 · Terminated

Recall details

Recalling firm

AMO Manufacturing USA, LLC

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

LZS

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,

Date initiated

2010-07-13

Date posted

2011-02-18

Date terminated

2012-06-22

Location

Milpitas, CA