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

Device Problems Improper or Incorrect Procedure or Method (2017); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems Red Eye(s) (2038); Burning Sensation (2146); Discomfort (2330)

Event Date 01/01/2012

Event Type  Other  

Event Description

I accidentally used clear care contact lens cleaning solution from (b)(4) to rinse my contact lens before placing it in my eye.Intense burning upon contact and then discomfort for several hours following a thorough rinse.Eye still red 8 hours later.Though this is clearly my fault for using the solution incorrectly, the bottle labeling (the older design with a picture of a contact lens and words no rub on the front) is too similar to other rinse and wear lens solutions.Very easy to confuse when one is in a rush and picking a bottle from a row of similar bottles.There must be a lot of the older design still out there, and i would think this constitutes a hazard.Medication administered to or used by the pt: no.Pt counseling provided: unk.Pt's age: adult (18-64 years).Reporter's recommendations: better bottle labeling.Possibly recall of older solutions with confusing packaging.(b)(4).

• Brand Name: CLEAR CARE
• Type of Device: CLEAR CARE CONTACT LENS
• Manufacturer (Section D): CIBA VISION CORPORATION
• MDR Report Key: 5187159
• MDR Text Key: 29944943
• Report Number: MW5057424
• Device Sequence Number: 0
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/08/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

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