BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Reported: October 9, 2024 Initiated: August 29, 2024 #Z-3310-2024
Product Description
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
Reason for Recall
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Details
- Recalling Firm
- CooperVision, Inc.
- Units Affected
- 607 lenses
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Location
- West Henrietta, NY
Frequently Asked Questions
What product was recalled? ▼
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.. Recalled by CooperVision, Inc.. Units affected: 607 lenses.
Why was this product recalled? ▼
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 9, 2024. Severity: Moderate. Recall number: Z-3310-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11