Reported Apr 16, 2014 · Terminated

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

Alcon LenSx, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alcon LenSx, Inc. · 33 Journey · Aliso Viejo, CA · 92656-5346

Is this the product you have?

  • Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
Lot codes and dates
  • (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
Amount recalled
75

Why it was recalled

Alcon LenSx received reports of unexpected downward motion of the gantry.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 16, 2014 · Data as of Sep 19, 6:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.