FDA Device recall Z-2982-2018
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)…
- FDA Device
- Class III
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class III 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)… by Alden Optical, citing vials labeled for the prescriptions contained incorrect lenses.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2982-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-07-03 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Alden Optical |
| Distribution | CA, GA, IL, MD, NC, NJ, NV, OH, OK, PA, TN, TX, UT |
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.
Reason
Vials labeled for the prescriptions contained incorrect lenses
Identifiers
| code_info | B3225920 UDI-(01)00785811435660/(10)18101PTC008 B3237210 UDI-(01)00785811435660/(10)18101PTC008 B3237220 UDI-(01)0078…B3225920 UDI-(01)00785811435660/(10)18101PTC008 B3237210 UDI-(01)00785811435660/(10)18101PTC008 B3237220 UDI-(01)00785811435660/(10)18101PTC008 B3237910 UDI-(01)00785811435660/(10)18101PTC008 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2982-2018%22
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