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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CHOAH INTERNATIONAL PRISM COLORED CONTACTS; PRISIM COLORED CONTACTS
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CHOAH INTERNATIONAL PRISM COLORED CONTACTS; PRISIM COLORED CONTACTS Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Corneal Scar (1793); Corneal Ulcer (1796); Irritation (1941); Pain (1994); Red Eye(s) (2038)
Event Date 11/26/2017
Event Type  Injury  
Event Description
I purchased cosmetic contacts from (b)(6) at (b)(6).I started wearing them off and on for a few weeks and i noticed that my left eye was red and irritated.So, i removed the contacts and my eye irritation worsened and became very painful.I laid down that evening with a cold compress on my eye and the next day, the pain was so excruciating and i was unable to see.I went to two emergency rooms ((b)(6) center referred me to (b)(6)) and was given antibiotics and penicillin and was then referred to an ophthalmologist who diagnosed me with an ulcer on my cornea and prescribed me steroid eye drops.I have seen him twice and have another appointment on (b)(6).My entire cornea was covered with an ulcer and now a month later the ulcer is healed however, i have permanent scar tissue directly in the center of my cornea which prevents me from seeing.
 
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Brand Name
PRISM COLORED CONTACTS
Type of Device
PRISIM COLORED CONTACTS
Manufacturer (Section D)
CHOAH INTERNATIONAL
MDR Report Key7168477
MDR Text Key96607621
Report NumberMW5074407
Device Sequence Number1
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 01/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Device Operator Lay User/Patient
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; Required Intervention; Disability;
Patient Age28 YR
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