FDA Device recall Z-3311-2024
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) wi…
- FDA Device
- Class II
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class II recall of Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) wi… by Coopervision, citing manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3311-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-29 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Coopervision |
| Distribution | US |
Product
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Reason
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Identifiers
| code_info | UDI-DI: N/A Lot Numbers: RB0444532 RB0450357 RB0450370 RB0450372 RB0450378 RB0450379 RB0450407 RB0450419 RB0450422 RB04…UDI-DI: N/A Lot Numbers: RB0444532 RB0450357 RB0450370 RB0450372 RB0450378 RB0450379 RB0450407 RB0450419 RB0450422 RB0450429 RB0450438 RB0450446 RB0450455 RB0450457 RB0450465 RB0450466 RB0450477 RB0450478 RB0450496 RB0450501 RB0450504 RB0450542 RB0450547 RB0450548 RB0450560 RB0450561 RB0450575 RB0450594 RB0450613 RB0450625 RB0450636 RB0450646 RB0450649 RB0450653 RB0450657 RB0450659 RB0450686 RB0450687 RB0450688 RB0450691 RB0450693 RB0450694 RB0450695 RB0450697 RB0450699 RB0450701 RB0450702 RB0450707 RB0450708 RB0450709 RB0450710 RB0450714 RB0450719 RB0450727 RB0450730 RB0450739 RB0450746 RB0450748 RB0450753 RB0450767 RB0450770 RB0450776 RB0450827 RB0450864 RB0450887 RB0450957 RB0451097 RB0451099 RB0451101 RB0451104 RB0451106 RB0451107 RB0451122 RB0451127 RB0451130 RB0451134 RB0451135 RB0451136 RB0451137 RB0451139 RB0451403 RB0451430 RB0451433 RB0451442 RB0451443 RB0451451 RB0451456 RB0451462 RB0451468 RB0451485 RB0451488 RB0451546 RB0451553 RB0451558 RB0451587 RB0451593 RB0451604 RB045 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3311-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.