Recall Z-3310-2024 ยท LPM Lenses, Soft Contact, Extended Wear
CooperVision, Inc.
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.
| Date | Sep 30, 2024 (initiated Aug 29, 2024) |
| Status | Open, Classified |
| Reason | Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity |
| Root cause | Process control |
| Action | CooperVision issued Urgent Medical Device Correction letter (Customer specific) beginning 8/30/24 to Distributors, Eye Care Practitioners, Consumers. Letter states reason for recall, health risk and action to take: Stop any further distribution of product from the designated lot numbers; " We recommend authorized distributors contact your accounts and Eye Care Practitioners contact your patients who have received the affected product with the enclosed draft Consumer Communication Letter, to be completed by the Eye Care Practitioner s office. " Please instruct any patients to return any affect |
| Quantity | 607 lenses |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.