Z-1445-2014Class II

Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions...

Name: Z-1445-2014 Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions...
Creator: Alcon LenSx, Inc.
Published: 2014-03-14
License: https://open.fda.gov/license/

Alcon Lensx, Inc. / initiated 2014-03-14 / Terminated / root cause: design

FDA source

Alcon LenSx, Inc. began a recall of Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation on 2014-03-14. FDA classified it as Class II and gives the reason as "Alcon LenSx received reports of unexpected downward motion of the gantry". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1445-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-14
Posted: 2014-04-09
Terminated: 2014-10-16
Recalling firm: Alcon Lensx, Inc.
Product: Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
Product code: OOE Ophthalmic Femtosecond Laser
Reason for recall: Alcon LenSx received reports of unexpected downward motion of the gantry.
Root cause tag: design
FDA 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, and a contact reference person. The letter also contained a section for customers to sign and return the page of the Notice to Alcon.
Quantity in commerce: 75
Distribution: Worldwide Distribution.
Product codes and lots: (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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1445-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1445-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-16	2014-04-09

Product code OOE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)