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U.S. Department of Health and Human Services

Class 2 Device Recall BIOFINITY XR TORIC

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 Class 2 Device Recall BIOFINITY XR TORICsee related information
Date Initiated by FirmAugust 29, 2024
Date PostedSeptember 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3310-2024
Recall Event ID 95299
Product Classification Lenses, soft contact, extended wear - Product Code LPM
ProductBIOFINITY 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.
Code Information UDI-DI: N/A Lot Numbers: RD0122830 RD0122954 RD0122963 RD0123016 RD0123055 RD0123135 RD0123147 RD0123159 RD0123160 RD0123172 RD0123187 RD0123193 RD0123197 RD0123206 RD0123212 RD0123250 RD0123254 RD0123261 RD0123265 RD0123268 RD0123284 RD0123294 RD0123307 RD0123321 RD0123323 RD0123327 RD0123346 RD0123347 RD0123379 RD0123382 RD0123404 RD0123405 RD0123408 RD0123419 RD0123428 RD0123433 RD0123442 RD0123488 RD0123492 RD0123499 RD0123507 RD0123535 RD0123551 RD0123587 RD0123595 RD0123610 RD0123615 RD0123619 RD0123628 RD0123646 RD0123657 RD0123667 RD0123675 RD0123698 RD0123701 RD0123705 RD0123728 RD0123730 RD0123734 RD0123751 RD0123818 RD0123827 RD0123857 RD0123863 RD0123897 RD0123915 RD0123945 RD0123960 RD0123970 RD0124002 RD0124026 RD0124043 RD0124060 RD0124099 RD0124137 RD0124209 RD0124210 RD0124215 RD0124225 RD0124241 RE0071577 RE0071578 RE0071598 RE0071606 RE0071607 RE0071613 RE0071615 RE0071616 RE0071617 RE0071619 RE0071620 RE0071622 RE0071623 RE0071624 RE0071627 RE0071629 RE0071636 RE0071641 RE0071656 RE0071758 RE0071807 RE0071821 RE0071827 RE0071830 RE0071836 RE0071840 RE0071853 RE0071858 RE0071863 RE0071864 RE0071869 RE0071873 RE0071879 RE0071881 RE0071883 RE0071889 RE0071892 RE0071897 RE0071905 RE0071906 RE0071923 RE0071926 RE0071942 RE0071943 RE0071947 RE0071953 RE0071995 RE0071996 RE0072056 RE0072271 RE0072283 RE0072297 RE0072481 RE0072502
FEI Number 3005724763
Recalling Firm/
Manufacturer		 CooperVision, Inc.
180 Thruway Park Dr
West Henrietta NY 14586-9798
For Additional Information ContactAnnette Nelson
585-756-9300
Manufacturer Reason
for Recall		Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
FDA Determined
Cause 2		Process control
ActionCooperVision 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 affected product to their Eye Care Practitioner for replacement or credit. " Within the next five (5) business days, please complete the attached Correction Response Form and fax it to 888-385-3217 or scan and email to: info@coopervision.com. If you have no lenses from these specified lots, please put 0 in Quantity ; " Dispose of the affected product in your inventory or that is returned to you. " Your account will be credited once the form is received. " If your patients have questions or complaints, please have them contact our customer services team at 800-341-2020, 9:00 AM 7:00 PM ET, Monday Friday, or they can visit CooperVision s website at coopervision.com/our-company/contact-us/complaint. Please note that if a credit is due to you, this will automatically be applied to your account once we have received and validated your Correction Response Form .
Quantity in Commerce607 lenses
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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