MAUDE Adverse Event Report: CIBA VISION CORPORATION CLEAR CARE

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Irritation (1941); Burning Sensation (2146); Eye Burn (2523); Chemical Exposure (2570)

Event Date 01/01/2013

Event Type  Other  

Event Description

Description: my husband has used clear care to clean his contacts before, but when he used it this time it caused burning and irritation after using it properly in the special container overnight.He thought it must be his contact lenses so he threw them out.I suggested that maybe the reaction in the case was too much (i'm really not an idiot) but didn't take time to investigate it further.Unfortunately, he took my advice and has severely burnt his eye.Even after flushing it and resting it overnight it is still burning and causing severe pain.Of course i'm upset with myself, but i'm more upset that nowhere on the label does it warn that it can be dangerous or cause eye injury.In a day and age when warnings are expected, a mild "if burning or irritation continues, seek professional assistance from an eye care professional" does not give any indication it can be that serious or cause anything more than irritation.Please let me know if i can do anything more to support improved labeling.Thank you.When and how was error discovered: use of the product - not because it was used improperly, but because it burned after using properly.Pt counseling provided: unk.Reporter's recommendations: i still do not know if the harm is permanent, but it has not healed yet.As stated above, more honest and appropriate wording such was "warning" and "danger" and "potentially serious damage" should be on the label.It should also say something to the effect to "seek immediate medical attention" rather than the mild "professional assistance" advice.(b)(6).

• Brand Name: CLEAR CARE
• Type of Device: CLEAR CARE
• Manufacturer (Section D): CIBA VISION CORPORATION
• MDR Report Key: 5187204
• MDR Text Key: 29953731
• Report Number: MW5057454
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1