Recall Z-0991-2018— Alden Optical
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: K052703. Product: ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.. 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 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
ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.
Reason for recall
Contact lenses lack sterility assurance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.