The Recall Desk

FDA (Devices) recall action 65558

Staar Surgical Co. recalled 2 products on 2013-07-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2013-07-24
Critical
0
Units
6,722

Why these products were recalled

STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2013-07-24

    Staar Surgical Recalls Intraocular Lenses Due to Glass Particles

    Staar Surgical is recalling specific Afinity and nanoFLEX intraocular lenses because glass particles may be present in the storage vials.

    Product
    Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2013-07-24

    Staar Surgical Recalls Intraocular Lenses Due to Glass Particles

    Staar Surgical is recalling nanoFLEX and Afinity intraocular lenses because glass particles may be present in the storage vials.

    Product
    nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.
    Category
    Distribution
    34 states