MAUDE Adverse Event Report: ALCON CLEAR CARE PLUS WITH HYDRAGLYDE MOISTURE MATRIX

Lot Number 280343F

Device Problem Insufficient Information (3190)

Patient Problems Blurred Vision (2137); Halo (2227)

Event Date 08/29/2017

Event Type  Injury  

Event Description

I normally purchase "clear care" contact lens cleaner, i accidentally purchased "clear care plus" on sunday.I cleaned my contacts with it sunday night, and they seemed fine on monday.I cleaned them again with clear care plus on monday night, and today (tuesday) i put them in around 5:40am, and i drove an hour to work and that seemed ok.Shortly after arriving at work i realized my vision was slightly cloudy or foggy.By 8am my vision was extremely cloudy, and any light sources had halos and rainbows around them.Since i live very far from where i work and i cannot drive without contact lenses i decided to drive home before my vision degraded further.Once i got home (9am) i removed the lenses but the cloudiness, halos, and rainbows persisted.My vision has been slowly returning to normal throughout the day and now (6pm) most of the cloudiness is gone but i am still extremely light sensitive.Dates of use: (b)(6), 2017.

• Brand Name: CLEAR CARE PLUS WITH HYDRAGLYDE MOISTURE MATRIX
• Type of Device: CLEAR CARE PLUS WITH HYDRAGLYDE MOISTURE MATRIX
• Manufacturer (Section D): ALCON
• MDR Report Key: 6838691
• MDR Text Key: 84826970
• Report Number: MW5071902
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• 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: 08/29/2017

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
• Device Expiration Date: 01/31/2019
• Device Lot Number: 280343F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 88