The Recall Desk

FDA (Devices) recall action 71411

Bausch & Lomb Surgical, Inc. recalled 2 products on 2015-07-29

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
2015-07-29
Critical
0
Units
—

Why these products were recalled

Haptics breaking during lens loading and insertion.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2015-07-29

    Bausch & Lomb SoFlex SE Intraocular Lens Recall for Haptic Breakage

    Bausch & Lomb is recalling SoFlex SE foldable intraocular lenses because haptics may break during loading and insertion.

    Product
    Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
    Category
    Distribution
    42 states