AMO Manufacturing USA, LLC Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International)
Brand
AMO Manufacturing USA, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Catalys-U and Catalys-I with Windows 7 Ultimate/Professional/Embedded Standard. Catalys-C with Windows 7 Embedded Standard. 0160-6020 and 0160-6010 with Windows 7 Professional/Embedded Standard.
AMO Manufacturing USA, LLC is recalling Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Cataly due to Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler servic. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WI
Page updated: Jan 10, 2026