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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRIGHT OCULAR ARTIFICIAL IRIS
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BRIGHT OCULAR ARTIFICIAL IRIS Back to Search Results
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes Cataract, Induced (1767); Corneal Edema (1791); Glaucoma (1875); Iritis (1940)
Date of Event 07/25/2016
Type of Reportable Event Serious Injury
Event or Problem Description
The bright ocular cosmetic artificial iris is manufactured by a company in the usa, but not usa approved (although the product website is very misleading in claiming that the device is "made from fda approved materials").Pt must travel to (b)(6) for these devices to be implanted.However, pts are quickly sent back to the us after surgery and many pts experience severe complications associated with this device.The current pt predictably suffered corneal decompensation, iritis, glaucoma, and cataract after having a bright ocular artificial iris placed to change his eye color.His surgery was done in (b)(6).The pt required explant of the device in both eyes.In the right he has required, cataract surgery, iris repair, and corneal transplantation.The left eye may need further surgery in the future for similar problems.The fda should consider a strongly worded warning regarding medical tourism for the implantation of these dangerous cosmetic artificial iris implants.
 
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Brand Name
BRIGHT OCULAR ARTIFICIAL IRIS
Common Device Name
BRIGHT OCULAR ARTIFICIAL IRIS
MDR Report Key5832715
Report NumberMW5063707
Device Sequence Number15172841
Product Code NIZ
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2016
Reporter Type Voluntary
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/26/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention; Disability;
Patient Age53 YR
Patient Weight79
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