MAUDE Adverse Event Report: NOVARTIS AKA ALCON LABORATORIES, INC. CLEAR CARE CONTACT LENS SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number 284742F

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Swelling (2091); Burning Sensation (2146)

Event Date 10/11/2018

Event Type  Injury  

Event Description

I purchased clear care brand contact lens solution.I used it but used a flat contact lens rather than the one that came with the product.I stored them overnight (8hrs) and when i inserted them my eyes immediately began burning and stinging severely.My eyes (8hrs later) are nearly swollen shut and i will be seeing an ophthalmologist to resolve the problem.Dates of use: (b)(6) 2018; otc product.Strength: "3 %" percent.Ophthalmic, routine overnight storage of soft contact lens.The problem did not stop after the person reduced the dose or stopped taking or using the product.

• Brand Name: CLEAR CARE CONTACT LENS SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): NOVARTIS AKA ALCON LABORATORIES, INC.
• MDR Report Key: 7965049
• MDR Text Key: 124081502
• Report Number: MW5080553
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2020
• Device Lot Number: 284742F
• 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: 65 YR
• Patient Weight: 86