MAUDE Adverse Event Report: ALCON (NOVARTIS) CLEAR CARE PLUS CONTACT LENS SOLUTION

Lot Number 260495F

Device Problem Insufficient Information (3190)

Patient Problems Corneal Abrasion (1789); Caustic/Chemical Burns (2549)

Event Date 07/17/2016

Event Type  Injury  

Event Description

Clear care contact lens solution caused chemical burns and corneal abrasion.Dates of use: (b)(6) 2016.Diagnosis or reason for use: contact lens wearer.Event abated after use stopped or dose reduced? no.

• Brand Name: CLEAR CARE PLUS CONTACT LENS SOLUTION
• Type of Device: CLEAR CARE PLUS
• Manufacturer (Section D): ALCON (NOVARTIS)
• MDR Report Key: 5808332
• MDR Text Key: 50081225
• Report Number: MW5063516
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 07/17/2016

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
• Device Expiration Date: 10/31/2017
• Device Lot Number: 260495F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 68