FDA (Devices) recall action 91607
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CooperVision is recalling Biofinity XR Toric contact lenses manufactured with misaligned axis, resulting in incorrect lens power and poor visual acuity.
CooperVision is recalling Biofinity XR Toric contact lenses due to misaligned axis in manufacturing that results in incorrect lens power. Users may experience poor visual acuity.