Recall Z-1445-2014 ยท OOE Ophthalmic Femtosecond Laser
Alcon LenSx, Inc.
Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
| Date | Apr 9, 2014 (initiated Mar 14, 2014) |
| Status | Terminated |
| Reason | Alcon LenSx received reports of unexpected downward motion of the gantry. |
| Root cause | Device Design |
| Action | Alcon LenSx Inc advised customers of a Medical Device Correction being initiated for specific serial numbers of the LenSx Laser System for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation. Alcon sent customer notification letters via mail during the week of March 17, 2014. The letter titled "Medical Device Correction", advised customers of the correction and provided: the product's description with serial number(s), description of the potential condition, advise on action to be taken by the user, transmission of the notice, |
| Quantity | 75 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.