Alcon Laboratories Ireland, LtdJanuary 15, 2015

FDA 483 - Alcon Laboratories Ireland, Ltd - January 15, 2015

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An FDA inspection of Alcon Laboratories Ireland, Ltd in Cork, Ireland, a medical device manufacturer, revealed a significant issue with Medical Device Report (MDR) submissions. The firm failed to submit MDRs within the required 30-day timeframe for devices that caused or contributed to serious injuries, with delays noted up to 111 days.

Company: Alcon Laboratories Ireland, Ltd
Inspection Date: January 15, 2015
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Karl Hezel

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ID · 7f776c53-4877-4a11-b59f-7857a2d79d25