MAUDE Adverse Event Report: COOPERVISION HYDRASOFT TORICXW CONTACT LENSES

Model Number TORICXW

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 05/24/2014

Event Type  Injury  

Event Description

Severe eye pain after wearing "hydrasoft toricxw" made by coopervision in (b)(4).I purchased a pair of hydrasoft toricxw contact lenses through (b)(4) in (b)(6) 2014.On (b)(6) 2014, i started wearing this pair, within 3 hours after put on the lenses, i started to feel some discomfort on my left eye, then the left eye produced lots of tears and i had to use paper tissue to wipe them off.By the time when i was driving home, my left eye condition progressed to have severe pain.After i got home, i immediately removed the lenses from my eyes and the intense pain lasted another 2 hours before it disappeared gradually.

• Brand Name: HYDRASOFT TORICXW CONTACT LENSES
• Type of Device: CONTACT LENS
• Manufacturer (Section D): COOPERVISION
• MDR Report Key: 3983525
• MDR Text Key: 18872913
• Report Number: MW5037618
• 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: 07/31/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: TORICXW
• Device Lot Number: "U146UD"
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2014
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 45