Z-2982-2018Class III

Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC...

Name: Z-2982-2018 Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC...
Creator: Alden Optical
Published: 2018-07-03
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2018-07-03 / Terminated / root cause: manufacturing process

FDA source

Alden Optical began a recall of 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... on 2018-07-03. FDA classified it as Class III and gives the reason as "Vials labeled for the prescriptions contained incorrect lenses". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2982-2018
Classification: Class III
Status: Terminated
Initiated: 2018-07-03
Posted: 2018-09-06
Terminated: 2020-02-28
Recalling firm: Bausch & Lomb Incorporated
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.
Product code: HQD Lens, Contact (Other Material) - Daily
Reason for recall: Vials labeled for the prescriptions contained incorrect lenses
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: B3225920 UDI-(01)00785811435660/(10)18101PTC008 B3237210 UDI-(01)00785811435660/(10)18101PTC008 B3237220 UDI-(01)00785811435660/(10)18101PTC008 B3237910 UDI-(01)00785811435660/(10)18101PTC008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2982-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2981-2018	Class III	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06
Z-2982-2018	Class III	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-06

Product code HQD

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)