MAUDE Adverse Event Report: ALCON CLEAR CARE; CONTACT SOLUTION

Device Problems Improper or Incorrect Procedure or Method (2017); Packaging Problem (3007)

Patient Problems Pain (1994); Red Eye(s) (2038)

Event Date 01/01/2015

Event Type  Other  

Event Description

After a long day of traveling and four hours of delayed departure, i finally made it to my hotel room at 10pm and discovered that i didn't have the tall case usually associated with this cleaning solution, i only had a flat one.I must admit that i can't read fine print any longer and had once stuck my finger in my eye after rubbing my contacts with this solution about five years ago.I definitely know not to do that again.However, because i can't read small writing anymore and it was late, i thought it would be okay to use a little bit of this solution in my flat case.Umm, not true! after inserting the contact, i had to claw it out of my eye! after dressing, i found a drugstore in the area and purchased a saline eye wash.But my eye was hurting so badly that my ceo excused me from his meeting and i went to the company's clinic.I assumed that i scratched my cornea trying to dig the contact lens out of my eye.I don't totally blame the mfr as i can see clearly on the large bottle in my home bathroom that it says not to use a flat case but for those of us that are already visually challenged, fine print is not our friend.Medication not administered to or used by the pt.I wore an eye patch for two days and since it was a friday and i was traveling home, found some eye antibiotic in my fridge and used that.After two days, my eye was slightly red but it didn't hurt to blink anymore.I feel very lucky.Visit to clinic/doctor.Missed work meeting.Pain for 2 days, required to wear an eye patch for 2 days.Large print/diagrams on every bottle.I have the travel size and can hardly read fine print these days - with or without reading glasses.I did not know until surfing the internet that the metal ring neutralizes the hydrogen peroxide.In my opinion, there needs to be almost a black line across the box or bottle and larger pictures on travel size.Traveling is hard anyway and being stuck in a medical situation makes it that much worse as you still have to get back home.Add'l comments: i think there should also be a warning about how difficult it might be to retrieve your contact lens from your eye if the solution has not been neutralized properly.I had to pry my eyes open while clawing at my contact lens to remove from my eyes.It was not an easy process.In addition, i've been using eye wash all weekend to try and continue to neutralize and normalize my eyes.I still wear glassed on the weekends so am not entirely dependent upon contact lens.I had glasses to get me through the day and back to the airport.If i hadn't had an old pair that i keep on standby in my travel bag, the situation would have been much, much worse as i can't drive without using glasses or contacts for corrected vision.(b)(4).

• Brand Name: CLEAR CARE
• Type of Device: CONTACT SOLUTION
• Manufacturer (Section D): ALCON
• MDR Report Key: 5353710
• MDR Text Key: 35546704
• Report Number: MW5059092
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1