Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc… — Class III medical device recall Z-2981-2018
Terminated recall by Alden Optical, reported 2018-09-12, distributed in CA, GA, IL, MD, NC, NJ, NV, OH…. Vials labeled for the prescriptions contained incorrect lenses
| Recall number | Z-2981-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alden Optical, Lancaster, NY, United States |
| Recall initiated | 2018-07-03 |
| Classified | 2018-09-06 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2020-02-28 |
| Distributed | CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX, UT |
| Quantity | 36 vials |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00785811435660, 00785811435677, 00865576000201, 00865576000218 |
| Serial numbers | B3235820 |
Product
Zenlens 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+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontToric) Zenlens TPC + MV- (Toric Peripheral Curve+Microvault). 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.
Reason for recall
Vials labeled for the prescriptions contained incorrect lenses
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2981-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.