Rigid Gas Permeable Contact Lenses and Lens Buttons used in the manufacture of Novalens. Firm-initiated recall ongoing. Firm-initiated recall ongoing. The pH of heparin solution that is applied to the inner surface of the tubes was found to be out of established pH limits, due to contaminated water. Firm- initiated recall complete.
Firm estimates that none of the product remains on the market.
The plates had trace contamination due to poor aspetic technique during manufacture. Adulterated - The article is unfit for food because it is contained in swollen cans which show evidence of detinning and the presence of hydrogen gas. Misbranded - The article package form and its label fails to bear an accurate statement of quantity of contents in terms of weight. Adulterated - The articles are class III medical devices which do not have the required approved premarket approval applications. FOR MAY 5, 1993.