MAUDE Adverse Event Report: ALCON CLEAR CARE PLUS WITH HYDRAGLYDE

Device Problem Insufficient Information (3190)

Patient Problems Irritation (1941); Red Eye(s) (2038); Visual Disturbances (2140); Burning Sensation (2146)

Event Date 11/17/2015

Event Type  Injury  

Event Description

Other serious/important medical incident: irritated eyes, halo vision.Was given a sample of alcon clear care plus with hydraglyde.I followed all directions and the solution caused my hydrogel contact lenses to become blurry and extremely irritating to wear (burning, redness).This was not a case of the solution not being neutralized as the solution was in the catalyst for over 7 hours and this was a brand new out of the box kit.The regular clear care product without the plus did not cause this reaction to my eyes and lenses.This is not laboratory data but i didn't see how over a 130 1 star reviews on (b)(6) complaining of the very same problem i described above should not prompt an fda investigation.(b)(6).Is the product over-the-counter: yes.Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.

• Brand Name: CLEAR CARE PLUS WITH HYDRAGLYDE
• Type of Device: CLEAR CARE PLUS WITH HYDRAGLYDE
• Manufacturer (Section D): ALCON
• MDR Report Key: 6116294
• MDR Text Key: 60682199
• Report Number: MW5066192
• 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: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR