The Recall Desk

FDA (Devices) recall action 95299

CooperVision, Inc. recalled 2 products on 2024-10-09

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.

Products
2
Announced
2024-10-09
Critical
0
Units
3,050

Why these products were recalled

Manufactured with a misaligned axis resulting in lenses with the incorrect power, 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.

1–2 of 2

  • HighFDA (Devices)··2024-10-09

    Contact lenses with misaligned axis may cause poor visual acuity

    CooperVision is recalling Biofinity Toric Multifocal soft contact lenses manufactured with misaligned axes resulting in incorrect optical power. Affected lenses may cause poor visual acuity.

    Product
    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2024-10-09

    BIOFINITY XR TORIC Contact Lenses Recalled for Misaligned Axis Defect

    CooperVision is recalling 607 BIOFINITY XR TORIC soft contact lenses due to a manufacturing defect with misaligned axis, resulting in incorrect power and poor visual acuity. The lenses were distributed in the US and Canada.

    Product
    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.
    Category
    Distribution
    0 states