Devices

Device Recall STAAR Surgical Collamer UltravioletAbsorbing Posterior Chamber Single

Model / Serial
CC4204BF and CC4204A
Product Classification
Ophthalmic Devices
Device Class
3
Implanted device?
Yes
Distribution
Worldwide Distribution - USA (nationwide) and the countries of South Africa, Slovakia, Mexico, Hong Kong, and Sri Lanka
Product Description
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).
Manufacturer
Staar Surgical Co.
1 Event
- Recall of Device Recall STAAR Surgical Collamer UltravioletAbsorbing Posterior Chamber Single

Manufacturer

Staar Surgical Co.

Manufacturer Address
Staar Surgical Co., 1911 Walker Ave, Monrovia CA 91016-4846
Manufacturer Parent Company (2017)
Staar Surgical Co.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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