Reported May 25, 2016 · Terminated
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
Alcon Research, Ltd.
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 Research, Ltd. · 6201 South Fwy · Fort Worth, TX · 76134-2099
Is this the product you have?
- LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
- Lot codes and dates
- Serial Numbers
81 of 81 codes
0511-A0130313-A3450713-A4550415-A0190912-A2580313-A3591213-A6130412-A1420412-A1371114-A9430212-A1120313-A3570813-A4691113-A6050314-A6970315-A9810913-A5301012-A2860515-A0371112-A2910515-A0421011-A0651012-A2841013-A5551211-A0861012-A2870912-A2450614-A7831113-A5961014-A9161011-A0620615-A0440913-A5060313-A3530615-A0500615-A0560912-A2471114-A9380712-A2020714-A8240113-A3200212-A1170614-A7820614-A7841112-A2940712-A2010514-A7490715-A0711111-A0671214-A9481013-A5420314-A6871213-A6140215-A9760312-A1351012-A2851013-A5480215-A9780412-A1391113-A586
- Serial Numbers
- Amount recalled
- 81 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.
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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