MAUDE Adverse Event Report: CLEAR CARE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Chemical Exposure (2570)

Event Date 01/01/2013

Event Type  Other  

Event Description

Description: i bought clear care disinfecting kit after failing to remove the lint stuck to my contacts.After the purchase, i immediately opened the package in my car outside the store.My contact was bothering my eye so bad from the day i did a quick glance at the large bottle and another at a smaller bottle.I assumed to be an after rinsing normal saline solution not realizing even the difference having never used this product and assuming all contact solutions "disinfected." thus i poured the solution directly into my eye and screaming as if i had squeezed acid into it.Now, 4 days later, i am still experiencing intense pain, swelling and constant redness.With no money to afford an er visit i have tried every home remedy i can think of with no relief.Outcome: visit to clinic/doctor.When and how was error discovered: when i poured this horrible improperly labeled solution into my eye.Pt counseling provided: unk.Reporter's recommendations: a warning in giant print across the front of label or tag warning seal before opening bottle.(b)(4).

• Brand Name: CLEAR CARE
• Type of Device: CLEAR CARE
• MDR Report Key: 5187221
• MDR Text Key: 30015372
• Report Number: MW5057465
• 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: 01/23/2013

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