Ioptex Pmma Anterior Chamber IOLs

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

Model 405 Spanflex Tm IOL

Generic Name

intraocular lens

PMA Number

P880085 ↗

FDA Product Code

HQL

Device Class

Class III

Regulation

21 CFR Part 886.3600

Advisory Committee

Ophthalmic

FDA Decision

APWD Approval withdrawn

• Sovereign High Vacuum Pack, Sovereign Compact High Vacuum Pack

  Class II

  FDA 510(k) K050648 Active Cleared 5 Apr 2005

• The Amo Ophthalmic Surgical System

  Class II

  FDA 510(k) K060366 Active Cleared 7 Apr 2006

• Lens Plus Rewetting Drops

  Class II

  FDA 510(k) K042562 Active Cleared 29 Jul 2005

• Vitrectomy Cutter and Accessories

  Class II

  FDA 510(k) K081681 Active Cleared 8 Oct 2008

• Blink Cl Lubricant Eye Drops

  Class II

  FDA 510(k) K032030 Active Cleared 25 Sep 2003

• One Series Ultra Cartridge, Model 1VIPR30

  Class I

  FDA 510(k) K081545 Active Cleared 2 Oct 2008

See all devices from Advanced Medical Optics, Inc. →