STAAR ICL Calculation Software Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Staar Surgical AG is recalling 543 units of STAAR ICL Calculation Software Version 8.00 due to a software coding issue with toric lens implantation orientation diagrams.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Staar Surgical AG initiated a voluntary recall of the STAAR ICL Calculation Software due to a software coding issue for calculating the implant orientation diagram printout for toric implantable collamer lenses.
Which Products Are Affected
The affected product is STAAR ICL Calculation Software, Software Version 8.00. The recall covers 543 units distributed worldwide, including US nationwide distribution in AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and additional countries. Lot Code: UDI (01)00840311346288(0812)8.00. The software error occurred for customers who generated an IOD for a toric implantation from April 13, 2026 to April 16, 2026 for multiple toric lens reservations for the same eye. Recall Number: Z-2509-2026. Classification: Class II. Recall initiated April 20, 2026.
What You Should Do
No specific consumer action steps are provided in the source data. Refer to the recall communication from Staar Surgical AG for further guidance.
Why This Matters
The software is used as an aid in calculating lens size, diopter power, and implantation orientation for toric ICLs, affecting physician selection and alignment.
Source
FDA recall event ID 99007, recall number Z-2509-2026. Recalling firm: Staar Surgical AG, Nidau, Switzerland.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,427 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.