Class 2 Device Recall

• Date Initiated by Firm: October 21, 2021
• Create Date: December 29, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0443-2022
• Recall Event ID: 88986
• PMA Number: P930016
• Product Classification: Excimer laser system - Product Code LZS
• Product: iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301
• Code Information: G300 with Windows XP. G301 with Windows 7 Embedded System.
• Recalling Firm/ Manufacturer: AMO Manufacturing USA, LLC; 510 Cottonwood Dr; Milpitas CA 95035-7403
• For Additional Information Contact: 408-273-4100
• Manufacturer Reason for Recall: Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.
• FDA Determined Cause: Software design
• Action: On 09/02/21, Microsoft "PrintNightmare" Vulnerability notices were sent to customers informing them of the upcoming software patches to remediate the vulnerability. This notice was posted on the recalling firm's website in the Security Advisories section. On 10/21/21 correction notices started being sent to customers. Customers were informed that Technical Service Representatives would contact then to schedule installation of the Windows OS patch. Customers were asked to do/ensure the following: 1) Complete the customer reply form, 2) To safeguard patients form potential harm and to inform them what to do in the event of product malfunction, customers were directed to specific parts of the Instructions for Use. 3) Confirm all measurements against baseline pre-operative manifest refraction and do not proceed when outside of recommended limits of difference, for sphere, cylinder and axis, as specified in the operators manual and training material. 4) Maintain manual records of patient measurements. 5) Ensure you comply with obligations under applicable privacy laws relating to putting in place safeguards in connection with personal information for patients. Customers with additional questions were encouraged to call Technical Support at 1 (800)- 511-0911.
• Quantity in Commerce: 711
• Distribution: US: CA, TX, FL, LA, MD, IA, MA, VA, SD, MN, MO, NC, TN, SC, WA, NV, OH, KY, IN, CO, NJ, OK, NH, UT, AR, NY, AK, ND, NE, IL, AL, HI, CT, DE, KS, GA, OR, MS, PA, MT, ME, MI, AZ, ID, WI, VT, NM, CA. OUS: Canada, Mexico, Russian Federation, Turkey, Brazil, Egypt, Iraq, Saudi Arabia, Jordan, Norway, Colombia, Germany, Malaysia, India, Oman, Azerbaijan, Canada, Slovakia, Lebanon, Spain, Ireland, Italy, South Korea, Bangladesh, Chile, Taiwan, Tunisia, Kazakhstan, Libya, Argentina, Singapore, Austria, Australia, Vietnam, Greece, Poland, Indonesia, Yemen, Great Britain, South Africa, Croatia, France, Czech Republic, Algeria, Thailand, Bulgaria, United Arab Emirates, Belgium, Japan, China, Nepal, Israel, Switzerland, Dominican Republic, Hong Kong, Portugal, Ecuador, Kuwait, Netherlands, Slovenia, Philippines
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LZS and Original Applicant = AMO Manufacturing USA, LLC