MAUDE Adverse Event Report: JANSSEN PHARMACEUTICA NV VISINE FOR CONTACT LENSES; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problems Irritation (1941); Swelling (2091); Burning Sensation (2146); Reaction (2414)

Event Date 10/18/2019

Event Type  Injury  

Event Description

I used the visine for contacts eye drops as directed with 2 drops in each eye.Within 3-5 minutes half my face and around eye lids as well as down my chin (every place the eye drops dripped after contact with my eye balls) began swelling, blistering, and became severely red and burning.I've used several different brands of contacts eye drops and never had a reaction before.This should be included on warning labels to include severe reaction to anywhere the drops touch, especially the face area is possible as well as the same reaction to your eyes.

• Brand Name: VISINE FOR CONTACT LENSES
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): JANSSEN PHARMACEUTICA NV
• MDR Report Key: 9233817
• MDR Text Key: 163935406
• Report Number: MW5090612
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 71