MAUDE Adverse Event Report: ALCON CLEAR CARE PLUS HYDRAGLYDE LENS SOLUTION

Model Number 65036339

Device Problem Insufficient Information (3190)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Date 05/18/2017

Event Type  No Answer Provided  

Event Description

Consumer purchased clear care plus hydraglyde lens solution on (b)(6) 2017.Used product as prescribed on bottle.I have been using the non "plus" version of this product for many years.I experienced extreme burning and discomfort in my eyes from this product for many hours and ended up having to throw away my contact lenses.Looked up product on (b)(6) to see what others were experiencing and the products gets 1 star (the lowest possible) with many people having a similar experience to mine.(b)(6).Not sure how a product like this can get to market with so many users experiencing very ill effects from it.(b)(6).Purchase date: (b)(6) 2017.The product was damaged before the incident: no.The product was modified before the incident: no.I left feedback of my experience at the (b)(6).I certify that i have reviewed the report and that the info provided in this report is true and accurate to the best of my knowledge, info and belief.Yes, you may include my report with any attachments on saferproducts.Gov.

• Brand Name: CLEAR CARE PLUS HYDRAGLYDE LENS SOLUTION
• Type of Device: CLEAR CARE PLUS HYDRAGLYDE LENS SOLUTION
• Manufacturer (Section D): ALCON
• MDR Report Key: 6597612
• MDR Text Key: 76395338
• Report Number: MW5070052
• 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: Patient
• Type of Report: Initial
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 65036339
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR