Alcon LenSx, Inc.

FDA Regulatory Profile

Alcon LenSx, Inc. appears in FDA public data with 1 recall, 2 510(k) clearances, 2 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1445-2014, Class II) was initiated on March 14, 2014. Its most recent 510(k) clearance was granted on December 12, 2012.

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1445-2014Class IIAlcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisionMarch 14, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K123120LENSX LASER SYSTEMDecember 12, 2012
K120732LENSSX LASER SYSTEMSeptember 6, 2012