FDA Device recall Z-0986-2018
Alden HP59 Sphere 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 HP59 Sphere 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-0986-2018 |
| 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 HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product Usage: The ALDEN SPHERE 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). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
Reason
Contact lenses lack sterility assurance.
Identifiers
| code_info | AZ139610 AZ139620 |
|---|
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-0986-2018%22
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