DAILIES AQUACOMFORT CONTACT LENSES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-13 for DAILIES AQUACOMFORT CONTACT LENSES manufactured by Alcon Research, Llc (formerly Known As Alcon Laboratories).

MAUDE Entry Details

• Report Number: MW5089022
• MDR Report Key: 8894076
• Date Received: 2019-08-13
• Date of Report: 2019-08-11
• Date of Event: 2019-08-10
• Date Added to Maude: 2019-08-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: DAILIES AQUACOMFORT CONTACT LENSES
• Generic Name: LENS, CONTACT, (DISPOSABLE)
• Product Code: MVN
• Date Received: 2019-08-13
• Lot Number: AQ549723
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ALCON RESEARCH, LLC (FORMERLY KNOWN AS ALCON LABORATORIES)

Device Sequence Number: 2

• Brand Name: DAILIES AQUACOMFORT CONTACT LENSES
• Generic Name: LENS, CONTACT, (DISPOSABLE)
• Product Code: MVN
• Date Received: 2019-08-13
• Lot Number: AQ549723
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ALCON RESEARCH, LLC (FORMERLY KNOWN AS ALCON LABORATORIES)

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-08-13