MAUDE Adverse Event Report: ALCON CLEAR CARE; SOFT CONTACT LENS CARE PRODUCT

Lot Number 260963F

Device Problems Device Operates Differently Than Expected (2913); Packaging Problem (3007)

Patient Problems Therapeutic Effects, Unexpected (2099); Chemical Exposure (2570)

Event Date 09/12/2017

Event Type  Injury  

Event Description

Other serious/important medical incident: chemically burned eye.I soaked my contact lens in what i thought was saline solution, but in reality it was soaked in clear care disinfectant and cleaning solution for contact lens, which contains acid and hydrogen peroxide and then i stuck my contact lens soaked in acid in my eye and now i have a "chemical burn in my eye" due to the lack of "visible warning labels" on the product and the fact that the bottle (packaging) looks exactly like all saline solutions bottles, a product that is so safe you can eat it.The clean care product and any product currently manufactured that has the potential to damage our eyes if used incorrectly needs to contain the following warning on the front and back of the actual bottle/package: "may result in blindness if put directly in eye" "can cause blindness".In large font.It is not ok to manufacture "hydrogen peroxide contact solution" products to 30 million people that can potentially permanently damage our eyes if used incorrectly and not have proper and visible warning labels on the product.All manufacturers should clearly label this fact.Thirty million people wear contact lenses; i should hope future packaging is up to par, so less people are suspectable to permanently damaging their eyes.Eyes are an important part of the human anatomy, companies and people need to protect each other.We need to do a better job of protecting human beings.Date the person first started taking or using the product: (b)(6) 2017.Date the person stopped taking or using the product: (b)(6) 2017.Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.Why was the person using the product: to soak contact lens in saline solution over night.One of 30 million contact lens wearers.

• Brand Name: CLEAR CARE
• Type of Device: SOFT CONTACT LENS CARE PRODUCT
• Manufacturer (Section D): ALCON
• MDR Report Key: 6868429
• MDR Text Key: 86439996
• Report Number: MW5072160
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2018
• Device Lot Number: 260963F
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 63