MAUDE Adverse Event Report: ALCON CLEAR CARE 355 ML

Lot Number 239362F

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 08/07/2015

Event Type  malfunction  

Event Description

My wife and i have both wear contact lenses and have been using clear care contact lens cleaning solution by alcon for several years.We recently had a bad experience with the product, which i wanted to draw attention to.The item was purchased, i believe from (b)(6).The bottle is labeled lot # 239362f, expiration 2017/01.I wear monthly prescription soft contact lenses and in the past approximately 2 weeks, began noticing significant irritation that began almost immediately after putting my contact lenses in.It was as if the contacts were dry, despite being left in clear care over night.I changed to brand new lenses, but the effect was the same.At first, i wrote it off as possibly a temporary physical condition, but it did not improve for several days.Eventually i took a closer look at the clear care case i was using and noticed i did not see the characteristic bubbles rising from the neutralizing disk when i put my contacts in for cleaning.Clear care is normally very bubbly when first used.I thought maybe there was a problem with the case, so i conducted a small experiment.I had a travel size clear care kit which includes a new bottle of solution and a new case (purchased separately with a different lot #).I took the brand new case and filled it with the solution from the old bottle.No bubbles at all; just like the old case.I then used the solution from the brand new bottle to fill both the old and new cases.Lots of bubbles in both.So both cases appeared to be working, but the old bottle of solution clearly was not.The simple conclusion is that whatever was in the bottle of clear care from lot #239362f that i had been using, it was not the normal clear care contact solution.It failed to bubble in either clear care neutralizing case, and it almost certainly led to the irritation i was experiencing for several days.(i would add: the irritation was not a burning that i would expect from failing to neutralize the product correctly.It was more of a dry feeling like getting lenses wet with water.I don't believe my issue was from failing to neutralize good solution.) i'm now quite concerned as i don't know what it was that i was soaking my contacts in everyday.Even if it was only harmless water, it likely wasn't cleaning our lenses correctly, which means i was wearing dirty and potentially contaminated lenses for up to a couple weeks without realizing it.I've stopped using the problem bottle and have now cleaned my lenses with working product, but i'm concerned that the company may have quality control issues, and who knows how many other people may have been exposed to this possibly bad batch.

• Brand Name: CLEAR CARE 355 ML
• Type of Device: CLEAR CARE 355 ML
• Manufacturer (Section D): ALCON
• MDR Report Key: 5001530
• MDR Text Key: 23120273
• Report Number: MW5055367
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 08/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2017
• Device Lot Number: 239362F
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1