BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with asti
Summary
The FDA issued a Class II for BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of by CooperVision, Inc.. Reason: Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity.
Details
Source
Device Recall
External ID
Z-3310-2024
Action Date
2024-10-09
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 607 lenses
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-29
Company
West Henrietta, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 218 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CooperVision, Inc. has 27 FDA actions in our database, including 24 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CooperVision, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CooperVision, Inc. have FDA actions?
CooperVision, Inc. has 27 FDA actions in our database, including 24 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3310-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29