LenSx Laser System — Class II medical device recall Z-1688-2016
Terminated recall by Alcon Research, Ltd., reported 2016-05-25. Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving report
| Recall number | Z-1688-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2016-04-14 |
| Classified | 2016-05-17 |
| Reported by FDA | 2016-05-25 |
| Terminated | 2017-10-20 |
| Countries outside the US | AE, AU, BR, CL, CR, CZ, DE, ES, FR, GR, HU, IN, IT, RO, SK, TH, TR, TW, UA |
| Quantity | 81 units |
| Serial numbers | 0112-A099, 0112-A101, 0113-A320, 0212-A112, 0212-A117, 0215-A976, 0215-A978, 0312-A129, 0312-A135, 0313-A345, 0313-A353, 0313-A357, 0313-A359, 0314-A685, 0314-A687, 0314-A697, 0315-A981, 0412-A137, 0412-A139, 0412-A142, 0413-A372, 0413-A380, 0415-A019, 0511-A013, 0512-A157 and 56 more |
Product
LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.
Reason for recall
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.
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-1688-2016. 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.