NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with otherwise nondiseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
Hazard
Contact lenses lack sterility assurance.
What You Should Do
Remedy
Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
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Products
NovaKone Daily Wear Soft contact; Catalog Number: AONKS54
Product Usage:
The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of ref
- UPC
- AZ154920 AZ154720
Units Affected
3