Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

STAAR Surgical medical devices: approvals, recalls and adverse events

Stock: STAA. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

77 supplements

Recalled products

0 class I

Adverse event reports

55K

3 deaths reported

How many recalls does STAAR Surgical have?

STAAR Surgical has 24 recalled medical device products in 13 recall actions in the records, 0 of them class I (the most serious kind). The newest recall started on Apr 20, 2026. In 2023 it had 11 recalled products.

How many medical devices has STAAR Surgical had cleared or approved?

24 510(k) clearances, 0 De Novo grants and 3 original PMA approvals for high-risk devices, plus 77 PMA supplements (changes to approved devices). The newest decision was on Mar 4, 2026.

How many adverse event reports name STAAR Surgical devices?

55,234 reports in total: 3 deaths, 36,746 injuries and 17,671 malfunctions were reported. 2,052 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	0	0	0	1
2025	0	0	0	3
2024	0	0	0	2
2022

Newest clearances and approvals

MicroSTAAR Injector System Cartridges
K172375 · 510(k) clearance · Sep 6, 2017
MicroSTAAR Injector System Cartridges
K152357 · 510(k) clearance · Oct 30, 2015
EPIPHANY INJECTION SYSTEM
K090161 · 510(k) clearance · Jun 9, 2009
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
K073591 · 510(k) clearance · Mar 13, 2008
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
K073586 · 510(k) clearance · Mar 13, 2008
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
P030016 · PMA approval · Dec 22, 2005
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
K032412 · 510(k) clearance · Jun 10, 2004
SURGE-FREE ASPIRATION ADAPTER
K020734 · 510(k) clearance · May 16, 2002
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
K983129 · 510(k) clearance · Dec 4, 1998
FOAM TIP INJECTOR
K980696 · 510(k) clearance · Sep 11, 1998
MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
K954600 · 510(k) clearance · Dec 21, 1995
SOFTRANS INJECTOR

Devices with the most adverse event reports

By product code, all years

Lens, Intraocular, Phakic (MTA, class 3)21,975
Phakic Toric Intraocular Lens (QCB, class 3)18,353
Intraocular Lens (HQL, class 3)12,638
Lens, Guide, Intraocular (KYB, class 1)1,579
Folders And Injectors, Intraocular Lens (Iol) (MSS, class 1)624
Unit, Phacofragmentation (HQC, class 2)50
Intraocular Pressure Lowering Implant (OGO, class 3)5
Lens, Intraocular, Toric Optics (MJP, class 3)5
Implant, Eye Valve (KYF, class 2)2

All device makers and procedures · STAA stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to STAA with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Reports	Deaths
2026	2	1,678	-
2025	0	2,052	-
2024	0	5,760	-
2023	11	5,789	-
2022	0	4,721	-
2021	0	4,955	2
2020	0	3,187	-
2019	0	2,496	1
2018	0	1,891	-
2017	0	2,018	-
2016	1	1,797	-
2015	0	1,714	-
2014	0	1,166	-
2013	2	1,105	-
2012	0	1,014	-

Newest recalls

Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is desig
Class II · Apr 20, 2026 · Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Class II · Jan 21, 2026 · 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 t
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Class II · Sep 29, 2023 · Their is a potential that intraocular implant devices may not meet specifications.
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
Class II · Sep 29, 2023 · Their is a potential that intraocular implant devices may not meet specifications.
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
Class II · Sep 29, 2023 · Their is a potential that intraocular implant devices may not meet specifications.
EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.
Class II · Sep 29, 2023 · Their is a potential that intraocular implant devices may not meet specifications.
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
Class II · Sep 29, 2023 · Their is a potential that intraocular implant devices may not meet specifications.
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Class II · Sep 29, 2023 · Their is a potential that intraocular implant devices may not meet specifications.
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Class II · Sep 29, 2023 · Their is a potential that intraocular implant devices may not meet specifications.
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Class II · Sep 29, 2023 · Their is a potential that intraocular implant devices may not meet specifications.