FDA Inspection
Alcon LenSx, Inc.Alcon LenSx, Inc. – FDA Inspection, Feb 10, 2014
Record Details
This FDA Inspection record concerns Alcon LenSx, Inc., with an inspection on February 10, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Alcon LenSx, Inc.
- Inspection Date
- February 10, 2014
- Product Type
- Devices
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ID · d093f6a3-b45e-4aee-b34d-3334a0d665d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 865838
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.198(e)(3)Device identification and control number
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Other FDA inspections of Alcon LenSx, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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