Recall Z-0134-2015— Cooper Vision Caribbean Corp.
Class III · Terminated
Class III FDA medical device recall by Cooper Vision Caribbean Corp., initiated 2014-09-17, terminated 2015-06-10. It names one FDA 510(k) clearance: K123202. Product: ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, 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.. Reason: Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification..
- Recalling firm
- Cooper Vision Caribbean Corp.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-09-17
- Terminated
- 2015-06-10
- Firm location
- Juana Diaz, PR, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, 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.
Reason for recall
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.