Recall Z-3310-2024— CooperVision, Inc.
Class II · Ongoing
Class II FDA medical device recall by CooperVision, Inc., initiated 2024-08-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity.
- Recalling firm
- CooperVision, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-29
- Firm location
- West Henrietta, NY, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.