# FDA recall Z-2509-2026

> **Staar Surgical AG** · Class II · device recall initiated 2026-04-20.

## Product

Product Name: STAAR ICL Calculation Software  Software Version: Version 8.00  Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment.    Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication.  Component: No

## Reason for recall

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

## Distribution

Worldwide - US Nationwide distribution including in the states and territory of 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 the countries of Austria, Australia, Belgium, Canada, Switzerland, Czech Republic, Germany Spain, Finland, France, Great Britain, Hong Kong, Ireland, Israel, India, Iran, Italy, Jordan, Korea, Kuwait, Kazakhstan, Morocco, Malaysia, Netherlands, Oman, Philippines, Poland, Saudi Arabia, Sweden, Singapore, Thailand, Turkey, Taiwan, Ukraine, USA, Vietnam.

## Key facts

- **Recall number:** Z-2509-2026
- **Recalling firm:** Staar Surgical AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-20
- **Report date:** 2026-06-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Nidau, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2509-2026

## Citation

> MORVS. FDA recall Z-2509-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2509-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*