BRIGHT OCULAR ARTIFICIAL IRIS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-26 for BRIGHT OCULAR ARTIFICIAL IRIS manufactured by .

Event Text Entries

[50841623] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5063707
• MDR Report Key: 5832715
• Date Received: 2016-07-26
• Date of Report: 2016-07-26
• Date of Event: 2016-07-25
• Date Added to Maude: 2016-07-29
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BRIGHT OCULAR ARTIFICIAL IRIS
• Generic Name: BRIGHT OCULAR ARTIFICIAL IRIS
• Product Code: NIZ
• Date Received: 2016-07-26
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2016-07-26