MAUDE Adverse Event Report: ALCON CLEAR CARE PLUS HYDRAGLYDE

Device Problem Insufficient Information (3190)

Patient Problem Visual Impairment (2138)

Event Date 10/18/2016

Event Type  Injury  

Event Description

Vision is very hazy after cleaning with clearcare hydraglyde.Lights cause terrible haze, making morning/night driving difficult.

• Brand Name: CLEAR CARE PLUS HYDRAGLYDE
• Type of Device: CLEAR CARE PLUS HYDRAGLYDE
• Manufacturer (Section D): ALCON
• MDR Report Key: 6043114
• MDR Text Key: 58055874
• Report Number: MW5065505
• 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: 10/18/2016

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 77