MAUDE Adverse Event Report: CIBA CLEAR CARE CONTACTS SOLUTION

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Eye Injury (1845); Red Eye(s) (2038); Swelling (2091); Visual Disturbances (2140); Burning Sensation (2146); Anxiety (2328); Depression (2361)

Event Date 01/13/2016

Event Type  Injury  

Event Description

Eye burned form clear care solution that my eye doctor used to soak my contacts for 5 minutes while he examined my eyes.It burned like crazy but he assure me i would be fine.My eye developed redness, tearing, scratchy gritty feeling, swollen, and it feels like it is coated with a thick membrane and lost some visual acuity.I suffer from anxiety and depression and it has worsened my mental states and has caused a lot of trouble with my daily functions; inability to focus, read with contacts in so often i just removed the contact and read with the naked eye as i am nearsighted.I worry long term damage has been done.If the eye doctor couldn't remember that clear care is not a short acting contact cleanser, how can we expect general contacts users to figure out something that is not a routine care as they are used to? this product should only be dispensed by pharmacist where it asks the pt to sign a disclaimer that clear care cannot be used for quick soaking and to avoid contact with eyes.A year later, i am still suffering with this eye injury.Did the problem stop after the person reduced the dose or stopped taking or using the product? no.

• Brand Name: CLEAR CARE CONTACTS SOLUTION
• Type of Device: CLEAR CARE CONTACTS SOLUTION
• Manufacturer (Section D): CIBA
• MDR Report Key: 5999448
• MDR Text Key: 56587705
• Report Number: MW5065182
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 49 YR
• Patient Weight: 61