FDA (Devices) recall action 94989
The FDA (Devices) publishes a recall like this one as 36 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 36 pages.
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
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.
Alcon Research LLC recalls ClearCut and A-OK ophthalmic surgical knives due to increased reports of sharpness issues that may affect surgical performance.
Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic surgical knives (Model 8065752438) due to increased complaint reports about sharpness.
Alcon is recalling 3,721 units of its 25GA Valved Entry System ophthalmic knives due to complaint reports about sharpness. The devices were distributed nationwide and internationally to 50+ countries.
Alcon is recalling ClearCut and A-OK Corneal/Scleral ophthalmic knives due to increased complaints about sharpness. The recall affects 6,972 units distributed nationwide and internationally.
Alcon is recalling 1,061 ophthalmic surgical knives due to reports of decreased sharpness. The affected instruments are used in eye surgery procedures and may not perform as intended.
Alcon is recalling ClearCut and A-OK ophthalmic surgical knives due to sharpness complaints. The defect affects 1,057 units distributed nationwide and internationally.
Alcon is recalling specific ophthalmic surgical knives due to reported sharpness defects. The recall affects 3,791 units distributed nationwide and internationally.
Alcon is recalling specific ophthalmic knives due to reports of inadequate sharpness. The affected instruments may not function as intended during surgical procedures.
Alcon is recalling ophthalmic knives for increased complaints of reduced sharpness. These surgical instruments require consistent blade sharpness for surgical precision in eye procedures.
Alcon is recalling surgical instrument packs that include ClearCut and A-OK brand ophthalmic knives due to increasing complaints about sharpness loss. The affected knives could impact surgical precision during eye procedures.
Alcon is recalling 145,248 ophthalmic knives (CLEARCUT SATINSLIT model 8065992745) due to increased complaint reports of inadequate sharpness. The surgical instruments were distributed nationwide and internationally.