MAUDE Adverse Event Report: BAUSCH + LOMB PEROXICLEAR; CONTACT LENS CLEANING SOLUTION

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

Patient Problems Irritation (1941); Pain (1994); Red Eye(s) (2038); Burning Sensation (2146); Excessive Tear Production (2235)

Event Date 10/26/2015

Event Type  Other  

Event Description

Peroxiclear.On (b)(6) 2015 i didn't use the peroxiclear case for my contacts; instead used a regular flat contact case.Put my contacts in it, and put peroxiclear in it.A few days later, i went to put my right contact in for the first time, and it burned badly for about an hour.After that it was very irritated, watering, red, and still painful.On (b)(6) 2015 i drove into work and had to put my sunglasses on, even though it wasn't bright out.When i got to work, i again put my sunglasses on in an indoor environment.I decided to make an eyepatch because my eye was still irritated, watery, red, and painful.My left eye has also been affected a bit from the start, even though the contact wasn't in it.Possibly some of the peroxiclear traveled over to the left eye? this situation occurred because i didn't see any label warning when doing it.As a consumer you're bombarded with warnings, generally speaking.I just didn't notice anything and figured it was an "eye" solution, so should be amenable to putting it in my eye.I am a pharmacist and i realize there are different components in eye products, but as a general rule, as a pharmacist i know that eye drops/products are meant for the eye.So i categorized this into an "eye" product and felt confident that it would be fine.Diagnosis or reason for use: contact lens.

• Brand Name: PEROXICLEAR
• Type of Device: CONTACT LENS CLEANING SOLUTION
• Manufacturer (Section D): BAUSCH + LOMB
• MDR Report Key: 5191528
• MDR Text Key: 30034080
• Report Number: MW5057577
• Device Sequence Number: 1
• 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: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 49