FDA Device recall Z-0987-2018
Alden HP49 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 HP49 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-0987-2018 |
| 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 HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 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 | AZ150010 AZ150020 AZ126720 AZ153710 AZ153720 AZ136110 AZ146910 AZ146920 AZ143710 AZ143720 AZ146610 AZ146620…AZ150010 AZ150020 AZ126720 AZ153710 AZ153720 AZ136110 AZ146910 AZ146920 AZ143710 AZ143720 AZ146610 AZ146620 AZ156210 AZ156220 AZ151510 AZ155210 AZ138410 AZ138420 AZ154810 AZ154620 AZ162310 AZ162320 AZ159810 AZ159820 AZ145220 AZ151120 |
|---|
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-0987-2018%22
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