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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES, INC. / ALCON RESEARCH, LLC CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS
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ALCON LABORATORIES, INC. / ALCON RESEARCH, LLC CLEAR CARE; ACCESSORIES, SOFT LENS PRODUCTS Back to Search Results
Device Problems Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017)
Patient Problems Foreign Body Sensation in Eye (1869); Burning Sensation (2146); Foreign Body In Patient (2687)
Event Date 01/01/2019
Event Type  Injury  
Event Description
Accidentally rinsed my eye with clear care contact cleaning solution instead of saline.I was feeling like i had a hair or something under my upper eye lid so i grabbed what i thought was saline and held my lid open and dumped a large amount of clear care into my eye instead; omg, fire, i then grabbed the other bottle which thankfully was saline and rinsed multiple times.My eye is no longer burning but it feels like stabbing where i thought i'd felt a small hair.It is excruciating especially when i close my eye.It even made my ear ache.I will try to see an eye doc tomorrow.That stuff needs to be in a whole different style of bottle as many of us contact users can not read labels when our contacts are not in our eyes.Maybe a flat bottle or one shaped like a water bottle or something obvious.Additional comments: have not seen an eye doc as of yet outcome: unknown at this time, still have stabbing pain several hours and many rinses later.Where did the error occur: patient's home.When and how was error discovered: omg, my eye was instantly on fire.Reporter's recommendations: not even bought the crap.(b)(6).(b)(4).
 
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Brand Name
CLEAR CARE
Type of Device
ACCESSORIES, SOFT LENS PRODUCTS
Manufacturer (Section D)
ALCON LABORATORIES, INC. / ALCON RESEARCH, LLC
MDR Report Key9446038
MDR Text Key170433783
Report NumberMW5091559
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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