ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens. ClearSight contact lenses are made from a material containing 55% water and 45% ocufilcon D, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. When placed on the cornea in its hydrated state, the ClearSight" (ocufilcon D) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
Recall
- Recall Number
- Z-0125-2010
- Event Number
- 53532
- Firm
- CooperVision Inc.
- FEI Number
- 3005724763
- Product Code
- MVN
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 28, 2009
- Posted
- November 9, 2009
- Terminated
- June 12, 2012
- Address
- 180 Thruway Park Dr W, Henrietta, NY, 14586-9798
Description
ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatism --- Name and Address on Label: CooperVision Hamble, SO31 4RF, UK, and Scottsville, NY 14546 USA --- Each lens is supplied sterile in a blister containing buffered saline solution. The blister is labeled with the base curve, diameter, dioptric power, manufacturing lot number, and expiration date of the lens. ClearSight contact lenses are made from a material containing 55% water and 45% ocufilcon D, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. When placed on the cornea in its hydrated state, the ClearSight" (ocufilcon D) Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
Thirty-eight lots of Ocufilcon D 55% 1-Day Toric Contact Lens with a modified packaging solution sold under the brand name ClearSight 1-Day Toric were inadvertently shipped into the US market prior to complete evaluation of the 510(k) by the FDA.
Urgent: Medical Device Recall - Contact Lens letters, dated 8/28/09, Response Forms, along with reorder forms and postage paid return labels were sent to the consignees via first class mail with instructions for returning the affected product. Customers are to examine their inventory and customer records to determine if they have any of the affected product. The affected products are to be returned and CooperVision will reimburse for all postage associated with the return and replace the lenses free of charge. Questions should be directed to Bonnie Tsymbal at (800) 341-2020 ext. 3210.
Nationwide Distribution
1440 cartons