MAUDE Adverse Event Report: ALCON RESEARCH, LLC. CLEAR CARE PLUS; ACCESSORIES, SOFT LENS PRODUCTS

Model Number H14124-1215

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Pain (1994); Red Eye(s) (2038); Burning Sensation (2146)

Event Date 10/13/2019

Event Type  Injury  

Event Description

Burning pain, redness, irritation.Used clear care plus solution in my contact lens and put it in my eye.Went to dr twice and still no relief.Fda safety report id# (b)(4).

• Brand Name: CLEAR CARE PLUS
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC.
• MDR Report Key: 9225155
• MDR Text Key: 163703690
• Report Number: MW5090576
• Device Sequence Number: 1
• Product Code: LPN
• 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: 10/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: H14124-1215
• Device Lot Number: 306045F
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 55