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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFMED

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SOFMED Back to Search Results
Model Number BREATHABLES ONE DAY
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Inflammation (1932); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137); Burning Sensation (2146); Discomfort (2330)
Event Date 12/11/2017
Event Type  Injury  
Event Description
Purchased sofmed contact lenses from (b)(6). I was persuaded to switch to these from other brands which i had successfully worn for years. Wore for 90 days (single-day-disposable), typically 8-10 hours per day. Upon reordering new 90-day supply, eyes became seriously inflamed after 10 days. Discontinued use immediately. Attempted to locate data on these medical devices, noticed there is no mfr anywhere on the external or internal packaging. I determined coopervision to be mfr, and contacted them to check lot number to verify that these were their units. Again, as there is no mfr listed in need to verify oem. (i have packaging, as proof of this). Upon research, i found history of massive contaminated recall by same. I suspect these are contaminated, as i have never had any issues like these. I have contacted them 3 times, asking for lot number verification, with no success. Symptoms: extremely red sclera. Apparent lesions on sclera (right eye). Copious tearing. Inflamed eyelids. Pain and discomfort on whole circumference of eyes. Blurring of vision. Discomfort when moving eyes in a normal manner. Rainbow flashing in vision (only happened once, so far, very scary). Burning sensation on entire front half of the eye. Entire body sweating (twice), with fingernail pain and skin sensitivity. Have samples of suspected product. Have inquired info having lab tests done.
 
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Brand NameSOFMED
Type of DeviceSOFMED
MDR Report Key7276193
MDR Text Key100465551
Report NumberMW5075320
Device Sequence Number0
Product Code LPL
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 02/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberBREATHABLES ONE DAY
Device Lot NumberTOO60443
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/15/2018 Patient Sequence Number: 1
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