865838
Alcon LenSx, Inc. — FEI 3008772169
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 10, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Aliso Viejo, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3377 | 21 CFR 820.198(e)(3) | Device identification and control number |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |