The Recall Desk

FDA (Devices) recall action 66844

CooperVision Inc. recalled 2 products on 2013-12-25

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
2013-12-25
Critical
0
Units
198

Why these products were recalled

Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.

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

  • ModerateFDA (Devices)··2013-12-25

    CooperVision Recalls Pro Clear 1 Day Sphere Contact Lenses for Incorrect Expiry Dates

    CooperVision is recalling 153 cartons of Pro Clear 1 Day Sphere contact lenses because the outer cartons display incorrect expiration dates, although the inner blisters are correct.

    Product
    Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-12-25

    CooperVision Recalls ClearSight Toric Contact Lenses for Incorrect Expiration Dates

    CooperVision is recalling specific lots of ClearSight Toric 1 day contact lenses because the outer cartons display incorrect expiration dates, though the inner blisters are correct.

    Product
    ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO31 4RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses for astigmatism
    Category
    Distribution
    0 states