MAUDE Adverse Event Report: COOPERVISION, INC. EQUATE DAILY CONTACT LENSES; LENSES, SOFT CONTACT, DAILY WEAR

Lot Number 111985050700150090

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091)

Event Date 06/20/2019

Event Type  Injury  

Event Description

Have been using same brand contact lenses for years.Recently, with a certain lot of lenses, i have had issues involving severe allergic reaction, seeming like chemical burn, inserted contacts and within an hour my eyes were so swollen and painful that i could not see.It required an emergency room visit as well as several vitis to the eye dr.It has taken prednisone eye drops for almost two weeks as well as almost a month for my eyes to heal from this.My current dr has said he has never seen such a severe reaction to daily lenses and agrees that there is something wrong with solution.I am unsure of how / where to have testing done.Fda safety report id# (b)(4).

• Brand Name: EQUATE DAILY CONTACT LENSES
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): COOPERVISION, INC.
• MDR Report Key: 8831016
• MDR Text Key: 152484118
• Report Number: MW5088388
• Device Sequence Number: 1
• Product Code: LPL
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 111985050700150090
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 87