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U.S. Department of Health and Human Services

Class 3 Device Recall Zen

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  Class 3 Device Recall Zen see related information
Date Initiated by Firm July 03, 2018
Create Date September 06, 2018
Recall Status1 Terminated 3 on February 28, 2020
Recall Number Z-2982-2018
Recall Event ID 80800
510(K)Number K071043  K071266  K033594  
Product Classification Lens, contact (other material) - daily - Product Code HQD
Product Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows:
Zen RC TPC (Toric Peripheral Curve)
Zen RC FT (Front Toric Optics)

Catalog Number: AOZNT

Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the correction of refractive arnetropia (myopia, hyperopia, and astigmatism) in aphakic and nonaphakic persons with non-diseased eyes.
Code Information B3225920 UDI-(01)00785811435660/(10)18101PTC008 B3237210 UDI-(01)00785811435660/(10)18101PTC008 B3237220 UDI-(01)00785811435660/(10)18101PTC008 B3237910 UDI-(01)00785811435660/(10)18101PTC008
Recalling Firm/
Manufacturer		 Alden Optical
6 Lancaster Pkwy
Lancaster NY 14086-9713
For Additional Information Contact SAME
716-937-9181
Manufacturer Reason
for Recall		 Vials labeled for the prescriptions contained incorrect lenses
FDA Determined
Cause 2		 Process control
Action The firm, Alden Optical, notified customers of an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" by phone and follow-up letter on 7/3/18. The letter described product, problem and actions to be taken. The customers were instructed to check your inventory; return the affected lenses via email with return shipping labels provided by email. Customers requested to notify patients if the lens has been dispensed or distributed, and have the patient return the lens(es), and complete the enclosed Business Response Card and return it to Alden Optical via U.S. Mail within 5 days. If you have any questions regarding this recall, please contact Alden Optical Customer Service at 1-800-253-3669.
Quantity in Commerce 4 vials
Distribution US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQD and Original Applicant = BAUSCH & LOMB, INC.
510(K)s with Product Code = HQD and Original Applicant = CONTAMAC LTD.
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