MAUDE Adverse Event Report: ALCON RESEARCH, LLC CLEAR CARE PLUS HYDRAGLYDE; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number H14926-0618

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Eye Injury (1845); Red Eye(s) (2038)

Event Date 05/04/2021

Event Type  Injury  

Event Description

Got started on new contacts used clear care solution before.Used to rinse and put lenses in my eyes.Md gave me sample, looked the same, i rinsed lens with solution and put the lens in and felt a great horrible burn in my eye.Started splashing water and removed lens; 6 hrs later my eye still red and sensitive.Will call the mds office in am.

• Brand Name: CLEAR CARE PLUS HYDRAGLYDE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LLC
• MDR Report Key: 11789824
• MDR Text Key: 249677302
• Report Number: MW5101214
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2022
• Device Lot Number: H14926-0618
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 72