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

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Pain (1994); Visual Impairment (2138)

Event Date 03/27/2021

Event Type  Injury  

Event Description

Have worn contact lenses for over 40 years without any problems.Purchased alcon clear care contact cleaner inadvertently believing i could also rinse with this product.Despite labeling, which did not catch my eye or distract me from use-i rinsed my contact placed it in my left eye.Excruciating pain, decreased vision.Anticipating follow up with ophthalmologist on monday once available.

• Brand Name: CLEAR CARE WITH HYDRAGLYDE
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH LLC.
• MDR Report Key: 11595231
• MDR Text Key: 243430294
• Report Number: MW5100406
• 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
• Report Date: 03/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 81