Z-0444-2022Class II

Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C...

Name: Z-0444-2022 Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C...
Creator: AMO Manufacturing USA, LLC
Published: 2021-10-21
License: https://open.fda.gov/license/

Advanced Medical Optics, Inc. / initiated 2021-10-21 / Open, Classified / root cause: software

FDA source

AMO Manufacturing USA, LLC began a recall of Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed... on 2021-10-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0444-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-21
Posted: 2021-12-29
Recalling firm: Advanced Medical Optics, Inc.
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)
Product code: OOE Ophthalmic Femtosecond Laser
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.
Root cause tag: software
FDA root 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: 546
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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0444-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0443-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-29
Z-0444-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-01-05	2021-12-29

Product code OOE

K113479Class IIOptimedica Catalys Precision Laser SystemOptimedica Corporation / cleared 2011-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)