Severity
Low
FDA Devices recall · Reported September 12, 2018
Vials labeled for the prescriptions contained incorrect lenses
Alden Optical recalled Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (R… - a low-severity action.
Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (R… was recalled by Alden Optical in September 12, 2018. Reason: Vials labeled for the prescriptions contained incorrect lenses. Check the official notice for the remedy. Verify recall #Z-2982-2018 with the FDA Devices before acting.
The recall
Alden Optical issued this low-severity FDA Devices recall-Vials labeled for the prescriptions contained incorrect lenses.
Sourced from official FDA Devices enforcement records. Verify recall #Z-2982-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2982-2018) was formally reported on September 12, 2018, with the manufacturer initiating the action on July 3, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Alden Optical is listed as the recalling firm, operating out of Lancaster, NY. Federal records list the affected scope as 4 vials.
The documented reason for this recall is: Vials labeled for the prescriptions contained incorrect lenses Distribution data in the federal record shows the product reached: US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
4 vials
Related Recalls
6
0 from same agency
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.
Vials labeled for the prescriptions contained incorrect lenses
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2982-2018 |
| Date reported | September 12, 2018 |
| Date initiated | July 3, 2018 |
| Recalling firm | Alden Optical |
| Firm location | Lancaster, NY |
| Affected scope | 4 vials |
| Distribution | US Distribution in the states of: CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX and UT. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 12, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.