510(k) Report

FDA applicant

Staar Sugical

Monrovia, CA2 decisions1994–19991 recall

FDA records 2 decisions for Staar Sugical (Monrovia, CA) from 1994 to 1999: 1 510(k) clearance and 1 original PMA approval. All are in product code KYB (Lens, Guide, Intraocular). 1 recall is linked to its devices.

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 Sugical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Staar Sugical since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • KYBLens, Guide, Intraocular1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K940593Disposable Microstaar InjectorStaar Sugical · 19942cite it

What has FDA decided for it lately?

  • P960033Staarvisc TM Sodium HyaluronateStaar Sugical · 1999
  • K940593Disposable Microstaar InjectorStaar Sugical · 19941 recall

All 2 as Staar Sugical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K940593STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses.May 2, 2016Class II

Other applicant names beginning “Staar”

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

Staar Surgical Co. 27Staar Japan 1