MAUDE Adverse Event Report: CLEAR CARE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn(s) (1757)

Event Date 01/01/2013

Event Type  Other  

Event Description

Description: i cleaned my contact lenses using my husband's bottle of clear care, which looks very similar to my own usual brand.The bottle is the same size, a blue color, a contact lens floating on the front.There's very little to indicate that this is not an ordinary saline solution.Of course, the peroxide solution burned my eye when i inserted the contact lens, and it was several minutes before i could even open my eye to take the contact lens out.After getting the lens out and recovering somewhat from the pain, i told my husband what had happened.He told me that he had done the exact same thing before he realized it was not an ordinary saline solution also.Now that i have searched on the product and examined the bottle carefully, i see my mistake, but given the similarity of the packaging to a that of common product that all contact lens users are familiar with, i think the packaging needs to the changed to prevent users from injuring themselves.Were other practioner's involved (perpetuate) in the error: no.Pt counseling provided: unk.Reporter's recommendations: the packaging is too similar to regular contact lens saline solution! it needs to be changed! (b)(4).

• Brand Name: CLEAR CARE
• Type of Device: CLEAR CARE
• MDR Report Key: 5187218
• MDR Text Key: 29978105
• Report Number: MW5057463
• 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: 09/24/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• 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