Class II

Medical Device Recall: 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.

CooperVision, Inc. · August 29, 2024

Reason for Recall

Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

States Affected

NATIONWIDE

Quantity Affected

607 lenses

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3310-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

CooperVision, Inc. Medical Device Recall: 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. | SafeCheck