Recall Z-1688-2016 ยท OOE Ophthalmic Femtosecond Laser
Alcon Research, Ltd.
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
| Date | Apr 14, 2016 |
| Status | Terminated |
| Reason | Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut. |
| Root cause | Software design (manufacturing process) |
| Action | Recall notification letters were sent to consignees on April 14, 2016. The letter details precautions to be taken by the surgeon and requests the consignee sign and return an acknowledgement form. |
| Quantity | 81 units |
| Distribution | United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120732 | LENSSX LASER SYSTEM Alcon Lensx, Inc., Sep 6, 2012 |