MAUDE Adverse Event Report: ALCON RESEARCH, LLC. DAILIES AQUA COMFORT PLUS LENSES, SOFT CONTACT, DAILY WEAR

Device Problems Break (1069); Product Quality Problem (1506)

Patient Problems Erythema (1840); Pain (1994); Burning Sensation (2146); Discomfort (2330)

Event Date 09/20/2020

Event Type  malfunction  

Event Description

Damage to eye, discomfort; hello, i use the dailies aqua comfort plus contacts. I bought out a new prescription last year. Almost every contact breaks, i have experienced eye discomfort, redness, and even burning. The contacts break as they are put into eye, which causes immense pain. I reached out the company over two weeks ago. To this date, no follow up was made to contact me and investigate this situation. I'm happy to provide more information. Thank you, (b)(6). Fda safety report id # (b)(4).

• Brand Name: DAILIES AQUA COMFORT PLUS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON RESEARCH, LLC.
• MDR Report Key: 12370269
• MDR Text Key: 268471299
• Report Number: MW5103505
• Device Sequence Number: 1
• Product Code: LPL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 08/25/2021 Patient Sequence Number: 1