LenSx Laser System
Medical device recall Z-1688-2016. Published in FDA’s Enforcement Report on May 25, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 25, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 81 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
81 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 0511-A013 0313-A345 0713-A455 0415-A019 0912-A258 0313-A359 1213-A613 0412-A142 0412-A137 1114-A943 0212-A112 0313-A357 0813-A469 1113-A605 0314-A697 0315-A981 0913-A530 1012-A286 0515-A037 1112-A291 0515-A042 1011-A065…
Every code shown here, 825 characters
Serial Numbers: 0511-A013 0313-A345 0713-A455 0415-A019 0912-A258 0313-A359 1213-A613 0412-A142 0412-A137 1114-A943 0212-A112 0313-A357 0813-A469 1113-A605 0314-A697 0315-A981 0913-A530 1012-A286 0515-A037 1112-A291 0515-A042 1011-A065 1012-A284 1013-A555 1211-A086 1012-A287 0912-A245 0614-A783 1113-A596 1014-A916 1011-A062 0615-A044 0913-A506 0313-A353 0615-A050 0615-A056 0912-A247 1114-A938 0712-A202 0714-A824 0113-A320 0212-A117 0614-A782 0614-A784 1112-A294 0712-A201 0514-A749 0715-A071 1111-A067 1214-A948 1013-A542 0314-A687 1213-A614 0215-A976 0312-A135 1012-A285 1013-A548 0215-A978 0412-A139 1113-A586 0312-A129 1011-A050 1213-A612 0314-A685 1112-A292 1012-A264 1015-A126 1111-A077 1013-A547 1114-A931 0112-A099 0112-A101 0413-A372 0413-A380 0512-A157 0612-A200 0715-A073 0811-A034 0815-A097 1013-A554 1113-A587
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 14, 2016.
- FDA classified it on May 17, 2016.
- FDA’s Enforcement Report published it on May 25, 2016.
- FDA terminated it on Oct 20, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Alcon Research, Ltd., of Fort Worth, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.