Food, drugs, devices › CooperVision, Inc.
Device recall: BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with asti
FDA enforcement event 95299 is a device recall by CooperVision, Inc. of West Henrietta, NY, initiated 29 Aug 2024 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. CooperVision, Inc. has 12 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
CooperVision, Inc., West Henrietta, NY.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3310-2024 | 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. | 607 lenses | Class II | Ongoing | 9 Oct 2024 |
| Z-3311-2024 | Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons. | 2443 lenses | Class II | Ongoing | 9 Oct 2024 |
Context
Other enforcement events for CooperVision, Inc.
All 12 events for CooperVision, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the country of Canada."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.