Zen RC Toric-Gas permeable contact lenses for Daily Wear in… recallZ-2982-2018 · Alden Optical · initiated Jul 3, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alden Optical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Vials labeled for the prescriptions contained incorrect lenses
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2982-2018
- Status
- Terminated
- Initiated by the company
- Jul 3, 2018
- Recalling firm
- Alden Optical
- Quantity
- 4 vials
- Product code
- HQD
- FDA submissions
- K033594, K071043, K071266
- Distribution
- US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.
Product description
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 (models, lots, serial numbers)
B3225920 UDI-(01)00785811435660/(10)18101PTC008 B3237210 UDI-(01)00785811435660/(10)18101PTC008 B3237220 UDI-(01)00785811435660/(10)18101PTC008 B3237910 UDI-(01)00785811435660/(10)18101PTC008
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Boston XO hexafocon ABausch & Lomb Incorporated · Lens, Contact (Other Material) - Daily2 recalls0 reports
Other devices under the same FDA submission
2 devices cleared under K033594, K071043, K071266 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Optimum Extra roflufocon DContamac Holdings Limited · Lens, Contact (Other Material) - Daily3 recalls1 report
- Optimum Extreme roflufocon EContamac Holdings Limited · Lens, Contact (Other Material) - Daily3 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 80800).
- Z-2981-2018 · TerminatedZenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microva…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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