MAUDE Adverse Event Report: ALCON CLEAR CARE; CLEANING AND DISINFECTING SOLUTION

Device Problem Insufficient Information (3190)

Patient Problems Conjunctivitis (1784); Keratitis (1944); Reaction (2414)

Event Date 05/20/2015

Event Type  Other  

Event Description

Both eyes involved.Pt sought medical attention.After using the product, the pt continued to wear her contacts.Prescribed for daily wear/ 2 week replacement.Lens worn one day.Clinical diagnosis: keratitis conjunctivitis.Moderate anterior chamber reaction.No ulcer, no infiltrates.Corneal staining of moderate severity (greater than 50%).No permanent scarring.Treated with to bradex qid ou.Event has resolved.Lens wear resumed.Event did not recur upon resumption of lens wear.

• Brand Name: CLEAR CARE
• Type of Device: CLEANING AND DISINFECTING SOLUTION
• Manufacturer (Section D): ALCON; 11460 johns creek parkway; johns creek GA 30097
• MDR Report Key: 4847610
• MDR Text Key: 5942899
• Report Number: MW5043093
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2015
• Patient Sequence Number: 1