MAUDE Adverse Event Report: ALCON ALCON CLEAR CARE PLUS HYDRAGLYDE

Lot Number 254058F

Device Problem Insufficient Information (3190)

Patient Problems Blurred Vision (2137); Halo (2227)

Event Date 07/30/2016

Event Type  Injury  

Event Description

Recently purchased otc alcon clear care hydraglyde formulation for contact.Noticed foggy, hazy vision and visuals of halos around light sources.The problem doesn't immediately resolve after removal of contact lenses, but adr still sustains after a few days.Dose or amount: 3 ounce(s), frequency: twice a day.Dates of use: (b)(6) 2016.

• Brand Name: ALCON CLEAR CARE PLUS HYDRAGLYDE
• Type of Device: ALCON CLEAR CARE PLUS HYDRAGLYDE
• Manufacturer (Section D): ALCON
• MDR Report Key: 5842899
• MDR Text Key: 51146446
• Report Number: MW5063794
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/31/2016

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 Lot Number: 254058F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR