Device Recall STAAR Surgical Collamer UltravioletAbsorbing Posterior Chamber Single

CC4204BF and CC4204A

Ophthalmic Devices

3

Yes

Worldwide Distribution - USA (nationwide) and the countries of South Africa, Slovakia, Mexico, Hong Kong, and Sri Lanka

Brand Name || STAAR Surgical Collamer¿ Ultraviolet-Absorbing Posterior Chamber Single || Piece Foldable Intraocular Lens || Common Names || Collamer single piece IOL || Collamer plate haptic IOL || The Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).