FDA Device recall Z-1445-2014
Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacof…
- FDA Device
- Class II
- terminated
- Published 2014-04-16
On 2014-04-16 the FDA classified a Class II recall of Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacof… by Alcon Lensx, citing alcon LenSx received reports of unexpected downward motion of the gantry.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1445-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-14 |
| Published | 2014-04-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alcon Lensx |
| Distribution | n/a |
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.
Identifiers
| code_info | (US) Serial Numbers: 0311-A007, 0511-A013, 0611-A017, 0611-A018, 0711-A021, 0811-A026, 0811-A027, 0811-A033,…(US) Serial Numbers: 0311-A007, 0511-A013, 0611-A017, 0611-A018, 0711-A021, 0811-A026, 0811-A027, 0811-A033, 0811-A035, 0911-A039, 0911-A045, 1011-A050, 1011-A062, 1111-A067, 1111-A073, 1111-A077, 1111-A080, 1111-A085, 1211-A086, 1211-A087, 1211-A088, 1211-A090, 0112-A099, 0212-A111, 0212-A116, 0212-A117, 0312-A126, 0312-A130, 0312-A135, 0412-A147, 0412-A152, 0412-A153, 0412-A155, 0512-A163, 0512-A167, 0512-A169. (International) Serial Numbers: 0611-A020, 0711-A022, 0711-A025, 0811-A030, 0811-A031, 0811-A032, 0811-A037, 0911-A038, 0911-A040, 0911-A041, 0911-A042, 1011-A053, 1011-A054, 1011-A055, 1011-A060, 1111-A069, 1111-A071, 1111-A072, 1111-A074, 1111-A075, 1111-A081, 1111-A082, 1211-A091, 1211-A094, 0112-A106, 0112-A107, 0112-A108, 0112-A109, 0212-A118, 0312-A121, 0312-A122, 0312-A123, 0312-A127, 0312-A132, 0512-A158, 0512-A160, 0512-A162, 0512-A164, 0512-A166. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1445-2014%22
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