Device Recall STA

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).

Product number: 20001601 , lot number 8542. Product was mislabeld as lower

Dental Devices

1

No

Worldwide distribution including the countries of Colombia, France, Scotland, Germany, Australia, Mexico, England, United Kingdom, Thailand; and (USA) Nationwide including the states of OK, CA, NJ, AZ, MD, LA, IL, PR, FL, NE, IN, TX, NH, NY, CO and PA.

Stainless Steel, Progressive Lower, .016: Arch Wires. || Intended for use in orthodontic treatment

Product number: 2004162201, lot number 9043. Product was mislabeld as upper

Dental Devices

1

No

Worldwide distribution including the countries of Colombia, France, Scotland, Germany, Australia, Mexico, England, United Kingdom, Thailand; and (USA) Nationwide including the states of OK, CA, NJ, AZ, MD, LA, IL, PR, FL, NE, IN, TX, NH, NY, CO and PA.

Stainless Steel, Natural,Lower, .016 x.022: Arch Wires. || Highland Metals, San Jose, CA 95125

Product number: 20041800, lot number 9321. Product was mislabeld as lower

Dental Devices

1

No

Worldwide distribution including the countries of Colombia, France, Scotland, Germany, Australia, Mexico, England, United Kingdom, Thailand; and (USA) Nationwide including the states of OK, CA, NJ, AZ, MD, LA, IL, PR, FL, NE, IN, TX, NH, NY, CO and PA.

Stainless Steel, Natural, Upper, .018": Arch Wires. || Highland Metals, San Jose, CA 95125

Product number: 20001801, lot number 9065. Product was mislabeld as upper

Dental Devices

1

No

Worldwide distribution including the countries of Colombia, France, Scotland, Germany, Australia, Mexico, England, United Kingdom, Thailand; and (USA) Nationwide including the states of OK, CA, NJ, AZ, MD, LA, IL, PR, FL, NE, IN, TX, NH, NY, CO and PA.

Stainless Steel, Natural, Lower, .018": Arch Wires. || Highland Metals, San Jose, CA 95125