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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MULTI-PURPOSE SOLUTION; CONTACT SOLUTION
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MULTI-PURPOSE SOLUTION; CONTACT SOLUTION Back to Search Results
Lot Number 142647
Device Problem Device Inoperable (1663)
Patient Problem Burning Sensation (2146)
Event Date 07/04/2017
Event Type  Injury  
Event Description
My wife and i recently used quality choice multi-purpose solution (lot 142647) and both pairs of contacts were ruined.At first, after keeping them in the solution overnight, the contacts burned extremely when placed in eyes.After burning subsided in about 30 mins, the contacts were cloudy and seemed to have lost their power.We have both been wearing contacts for many years.This was not user error.The solution is too strong and ruins the contacts after storage.Even after cleaning with other solution, the burning is removed, but the contacts no longer work.Name of the company that makes (or compounds) the product: (b)(4)."is the product over-the-counter: yes, how was it used: ophthalmic." quantity: 12 ounce(s).Date of use: (b)(6) 2017."did the problem stop after the person reduced the dose or stopped taking or using the product: no, did the problem return if the person started taking or using the product again: yes." tried to contact the company, however the online notice does not work.
 
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Brand Name
MULTI-PURPOSE SOLUTION
Type of Device
CONTACT SOLUTION
MDR Report Key6696899
MDR Text Key79746133
Report NumberMW5070884
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date09/30/2018
Device Lot Number142647
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age45 YR
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