Clerio Vision Recall 87421
Description: EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
Clerio Vision Recall 87421 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1352-2021 |
| Event ID | 87421 |
| Event Description | EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland. |
| Quantity | 153 lenses |
| Recall Reason | Contact lenses may be mislabeled with the incorrect lens power. |
| Device Classification | 20210414 |
| Device Code Info | Lot Number: 0114511565, UPC Code: 675506700657 (6 pack), 675506668650 (individual) |
| Center Classification Date | 20210405 |
| Recall Initiation Date | 20210216 |
| Recalling Firm | Clerio Vision |
| Initial Notification | Telephone |
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