Recall Z-1445-2014— Alcon LenSx, Inc.
Class II · Terminated
Class II FDA medical device recall by Alcon LenSx, Inc., initiated 2014-03-14, terminated 2014-10-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.. Reason: Alcon LenSx received reports of unexpected downward motion of the gantry..
- Recalling firm
- Alcon LenSx, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-03-14
- Terminated
- 2014-10-16
- Firm location
- Aliso Viejo, CA, United States
Product description
Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
Reason for recall
Alcon LenSx received reports of unexpected downward motion of the gantry.
Data sourced from openFDA. This site is unofficial and independent of the FDA.