Recall Z-0981-2018— Alden Optical

Name: FDA recall Z-0981-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-03

Class II · Terminated

Class II FDA medical device recall by Alden Optical, initiated 2017-11-03, terminated 2018-06-19. It names one FDA 510(k) clearance: K102557. Product: 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.. Reason: Contact lenses lack sterility assurance..

Recalling firm: Alden Optical
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Terminated: 2018-06-19
Firm location: Lancaster, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K102557 — NOVAKONE SPHERICAL AND TORIC LENSESAlden Optical Labs., Inc.·cleared 2011-04-26

K-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

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.

Reason for recall

Contact lenses lack sterility assurance.

Data sourced from openFDA. This site is unofficial and independent of the FDA.