# FDA 483 - Alcon Laboratories Ireland, Ltd - July 07, 2016

Source: https://www.globalkeysolutions.net/records/483/alcon-laboratories-ireland-ltd/8317d27e-cb1e-40e6-a053-d6ddd14c47d6

> FDA 483 for Alcon Laboratories Ireland, Ltd on July 07, 2016. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcon Laboratories Ireland, Ltd
- Inspection Date: 2016-07-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Alcon Laboratories Ireland, Ltd in Cork was inspected by the FDA from July 4-7, 2016, and received a Form 483 with two observations. The inspection revealed significant issues with the timely submission of Medical Device Reports (MDRs) for serious injuries related to their AcrySof IQ Natural Singlepiece Intraocular Lenses, which was a repeat observation. Additionally, the firm's corrective and preventive action (CAPA) procedures were found to be inadequate, as previous corrective actions for late MDRs were ineffective.

## Related Documents

- [483 - 2015-01-15](https://www.globalkeysolutions.net/records/483/alcon-laboratories-ireland-ltd/7f776c53-4877-4a11-b59f-7857a2d79d25)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

Company: https://www.globalkeysolutions.net/companies/alcon-laboratories-ireland-ltd/972519f4-01dd-49ce-9b9a-3eef6704cc44

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd