FDA (Devices) recall action 77023
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.
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.
Abbott Medical Optics is recalling Healon 5 Pro ophthalmic solution because some units may contain microscopic glass particles from manufacturing damage.
Abbott Medical Optics is recalling Healon medical devices because certain lots may contain microscopic glass particles from manufacturing damage.
Abbott Medical Optics is recalling Healon GV due to a remote possibility of microscopic glass particles from manufacturing damage.
Abbott Medical Optics is recalling Healon Pro ophthalmic solutions because manufacturing damage may have introduced microscopic glass particles.
Abbott Medical Optics is recalling Healon Duet units because they may contain microscopic glass particles from manufacturing damage.
Abbott Medical Optics is recalling Healon V due to a remote possibility of microscopic glass particles from manufacturing damage.