510(k) Report

FDA applicant

Staar Surgical Co.

Monrovia, CA27 decisions1983–20179 recalls

FDA records 27 decisions for Staar Surgical Co. (Monrovia, CA) from 1983 to 2017: 24 510(k) clearances and 3 original PMA approvals. Most are in product codes KYB (Lens, Guide, Intraocular) and HQC (Unit, Phacofragmentation). Its devices cite 12 predicates, 3 of them its own earlier devices. 9 recalls are linked to its devices.

FDA’s records also spell it “STAAR Surgical Company”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Staar Surgical Co.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008: 22009: 12015: 12017: 1
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2023: 72026 (partial year): 1
2007high 7 (2023) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Staar Surgical Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Staar Surgical Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • KYBLens, Guide, Intraocular7decisions
  • HQCUnit, Phacofragmentation6decisions
  • MSSFolders And Injectors, Intraocular Lens (Iol)5decisions
  • HQLIntraocular Lens2decisions
  • KYFImplant, Eye Valve1decision
  • HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered1decision

Also: HNR (1), JSM (1), KYG (1), MTA (1).

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K980696Foam Tip InjectorStaar Surgical Co. · 19983cite it
  • K983129Disposable Microstaar Injector (Model Msi-P1)Staar Surgical Co. · 19982cite it
  • K875099Molteno Valve SetonStaar Surgical Co. · 19882cite it
  • K913626Softrans InjectorStaar Surgical Co. · 19912cite it
  • K861085Elastic Lens Injector TMStaar Surgical Co. · 19861cites it
  • K073591Microstaar Msi Injector Foam Tip SystemStaar Surgical Co. · 20081cites it

What has FDA decided for it lately?

  • K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2017
  • K152357MicroSTAAR Injector System CartridgesSTAAR Surgical Company · 2015
  • K090161Epiphany Injection SystemStaar Surgical Co. · 2009
  • K073591Microstaar Msi Injector Foam Tip SystemStaar Surgical Co. · 2008
  • K073586Microstaar Indigo Injector Foam Tip SystemStaar Surgical Co. · 2008
  • P030016Visian Icl (Implantable Collamer Lens)STAAR Surgical Company · 20058 recalls
  • K032412RE-Useable Microstaar Injector, Msi-SStaar Surgical Co. · 2004
  • K020734Surge-Free Aspiration AdapterStaar Surgical Co. · 2002

All 24 as Staar Surgical Co. →All 3 as STAAR Surgical Company →

What has been recalled?

9 recalls linked to its devices; the latest:

  • P030016EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5Jan 21, 2026Class II
  • P030016EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens.Sep 29, 2023Class II
  • P030016EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.Sep 29, 2023Class II
  • P030016EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.Sep 29, 2023Class II
  • P030016EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.Sep 29, 2023Class II
  • P030016EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.Sep 29, 2023Class II

Other applicant names beginning “Staar”

FDA records each applicant name separately; these may or may not be the same firm.

Staar Sugical 2Staar Japan 1