Alcon LenSx, Inc.

FDA establishment 3008772169, Aliso Viejo, California, United States. Part of Alcon LenSx's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.

Inspections: 2
Official action indicated: 1
Last inspection ended: Feb 10, 2014
Warning letters: 0

Most Cited at This Site

Inspections citing each reference

Inspections

2 inspections, newest first

Ended	Product and area	Citations	Classification
Feb 10, 2014	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices	5 cited references 21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not reviewed, evaluated, and investigated where necessary. 21 CFR 806.10(a)(1). Report of risk to health A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. 21 CFR 820.198(e)(3). Device identification and control number Records of complaint investigations do not include device identifications and control numbers used. 21 CFR 803.50(b)(1). Reporting Information Reasonably Known An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer. 21 CFR 820.100(a)(4). CAPA verification/validation of corrective/preventive action Corrective and preventive actions have not been verified or validated to ensure that the action is effective and does not adversely affect the finished device.	Voluntary Action Indicated (VAI)
Aug 2, 2012	Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices	3 cited references 21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record. 21 CFR 820.40. Procedures not adequately established or maintained Document control procedures have not been adequately established. 21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.	Official Action Indicated (OAI)

Identifiers

FEI number: 3008772169
FDA firm profile: Data Dashboard
Company: Alcon LenSx

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters