FDA Device recall Z-0989-2018
Alden Classic 55 Toric Daily Wear Soft contact
- FDA Device
- Class II
- terminated
- Published 2018-03-21
On 2018-03-21 the FDA classified a Class II recall of Alden Classic 55 Toric Daily Wear Soft contact by Alden Optical, citing contact lenses lack sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0989-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-03 |
| Published | 2018-03-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Alden Optical |
| Distribution | US |
Product
Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.
Reason
Contact lenses lack sterility assurance.
Identifiers
| code_info | AZ133020 |
|---|
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-0989-2018%22
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