Staar Surgical recalls

Staar Surgical has 16 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 24 Jun 2026. 13 are still ongoing. 2 were reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls16since 2013

Last 12 months2reported

Class I00% of total

Ongoing13latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 1 0 0May 1 0 0Aug 0 0

Severity split

Class I 0 0%Class II 16 100%Class III 0 0%

Why staar surgical is recalled

Product types

By year

2026213%
20231169%
201616%
2013213%

Ongoing staar surgical recalls

13 active

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Staar ICL Calculation recalled by Staar Surgical AG	Staar Surgical	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	EVO+ Visian Toric Implantable Collamer Lens (TICL) recalled	Staar Surgical	Other	N/A
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states

All staar surgical recalls, newest first

16 total

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Staar ICL Calculation recalled by Staar Surgical AG	Staar Surgical	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS II	EVO+ Visian Toric Implantable Collamer Lens (TICL) recalled	Staar Surgical	Other	N/A
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO +Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
22 Jun 2016Device	CLASS II	Staar AQ Cartridge-FP, guide and delivery system recalled	Staar Surgical	Device Malfunction	CA
24 Jul 2013Device	CLASS II	Afinity CQ2015A Intraocular Lens The visual correction recalled	Staar Surgical	Particulate Matter	Nationwide
24 Jul 2013Device	CLASS II	nanoFLEX CC4204A Intraocular Lens Correct aphakia recalled	Staar Surgical	Particulate Matter	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.