MAUDE Adverse Event Report: CIBA VISION CORPORATION CLEAR CARE; CONTACT SOLUTION

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Red Eye(s) (2038); Burning Sensation (2146)

Event Date 01/01/2015

Event Type  Other  

Event Description

Description: didn't know that a peroxide deep clean solution had to be put in a separate case, resulted in burning of my left eye.Flushed it with water for 30 min and had severe redness for the duration of the day.Currently still unsure of how badly the chemicals hurt me, may need to seek eyecare medical attention tomorrow.Medication not administered to or used by the pt.Where did the error occur: pt's home.A better warning label that says it's different from multipurpose solution and that it is dangerous at the (b)(6) under the brand name.(b)(6).

• Brand Name: CLEAR CARE
• Type of Device: CONTACT SOLUTION
• Manufacturer (Section D): CIBA VISION CORPORATION
• MDR Report Key: 5406522
• MDR Text Key: 37440227
• Report Number: MW5059941
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1