Data Foundry

Medical device recalls 2014

Alcon LenSx Ophthalmic Laser — Class II medical device recall Z-1445-2014

Terminated recall by Alcon LenSx, Inc., reported 2014-04-16. Alcon LenSx received reports of unexpected downward motion of the gantry.

Recall numberZ-1445-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAlcon LenSx, Inc., Aliso Viejo, CA, United States
Recall initiated2014-03-14
Classified2014-04-09
Reported by FDA2014-04-16
Terminated2014-10-16
Quantity75
Serial numbers0112-A099, 0112-A106, 0112-A107, 0112-A108, 0112-A109, 0212-A111, 0212-A116, 0212-A117, 0212-A118, 0311-A007, 0312-A121, 0312-A122, 0312-A123, 0312-A126, 0312-A127, 0312-A130, 0312-A132, 0312-A135, 0412-A147, 0412-A152, 0412-A153, 0412-A155, 0511-A013, 0512-A158, 0512-A160 and 50 more

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1445-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.