Recall Z-0982-2018 ยท LPL Lenses, Soft Contact, Daily Wear
Alden Optical
NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with otherwise non-diseased eyes and who possess refractive astigmatism not exceeding 10 Diopters.
| Date | Nov 3, 2017 |
| Status | Terminated |
| Reason | Contact lenses lack sterility assurance. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 33 |
| Distribution | Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102557 | NOVAKONE SPHERICAL AND TORIC LENSES Alden Optical Labs., Inc., Apr 26, 2011 |