Nidau, N/A, Switzerland
Staar Surgical AG recalls
2 recalls recorded since 2018, most recently on 20 April 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 April 2026
- Reason
- 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, Aus
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2509-2026
- 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
Ongoing Class II Medical devices
- Recall started
- 21 January 2026
- Reason
- Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
- Distribution
- International distribution to the countries of India, Iran, Korea, Saudi Arabia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1480-2026
- EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.