MAUDE Adverse Event Report: ALCON AQUA COMFORT PLUS DAILIES CONTACTS; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number N0641516

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Irritation (1941); Discomfort (2330)

Event Date 03/30/2018

Event Type  Injury  

Event Description

About 5 mins after placing daily use contact in eye, contact began to feel irritated.After wiping my eye, the contact slid to the back of my eye.By blinking and moving my eye around, half of the contact came into view and i could retrieve it.My wife had to retrieve the other half from my eye.I experienced extreme discomfort.No permanent injury occurred to my knowledge.Product info: alcon aqua comfort plus dailies lot n0641516, exp 03/2021.

• Brand Name: AQUA COMFORT PLUS DAILIES CONTACTS
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): ALCON
• MDR Report Key: 7395301
• MDR Text Key: 104431107
• Report Number: MW5076282
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• 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: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2021
• Device Lot Number: N0641516
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 102