The Recall Desk

FDA (Devices) recall action 73777

Alcon Research, Ltd. recalled 3 products on 2016-05-25

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2016-05-25
Critical
0
Units
339,149

Why these products were recalled

The product has potential to leak beyond their design specification.

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.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2016-05-25

    Alcon Recalls 23G and 25G Valved Trocar Cannula Custom Paks

    Alcon Research, Ltd. is recalling 30,701 units of 23G and 25G valved trocar cannula Custom Paks because the products have the potential to leak beyond their design specification.

    Product
    Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-05-25

    Alcon Recalls 23G and 25G Constellation Totalplus Paks for Potential Leakage

    Alcon Research, Ltd. is recalling 225,000 units of 23G and 25G Constellation Totalplus Paks because the products have the potential to leak beyond their design specifications.

    Product
    23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-05-25

    Alcon Valved Entry System Recalled for Potential Leakage

    Alcon Research, Ltd. is recalling 83,448 units of 23G and 25G Valved Entry Systems because they may leak beyond design specifications.

    Product
    Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
    Category
    Distribution
    1 state