ARTIFICIAL IRIS IMPLANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-29 for ARTIFICIAL IRIS IMPLANT manufactured by Brightocular.

Event Text Entries

[44462357] I did brightocular artificial iris implant in (b)(6) 2013 in (b)(6) by doctor (b)(6) at (b)(6) eye care. Reason i am writing is the company which gave the artificial iris implant is brightocular which also has name as steller devices, (b)(4) this is their site: (b)(4). I paid them (b)(6) for doing this procedure. They are doing this on a sympathetic tone by projecting this procedure for aniridia, heterochromia, but they are purely doing this for cosmetic purpose as you can see this in their (b)(6) channel brightocular. Sad thing is after 3 years in (b)(6) i came back with severe cornea edema and glaucoma. I am very sad by this event and these people are saying that they are waiting for fda approval for this cosmetic iris implant. Many celebrities from usa also did this like (b)(6), (b)(6). I am begging you to take action against these guys since they are making many healthy people's vision blind. Please check (b)(6) videos. Many people do this for (b)(6) u. S. Dollars and they do surgeries in (b)(6), etc. But implant supplier who take 1000's of dollars are (b)(6), (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5062053
• MDR Report Key: 5629973
• Date Received: 2016-04-29
• Date of Report: 2016-04-29
• Date of Event: 2015-09-02
• Date Added to Maude: 2016-05-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• 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: ARTIFICIAL IRIS IMPLANT
• Generic Name: IRIS IMPLANT
• Product Code: NIZ
• Date Received: 2016-04-29
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BRIGHTOCULAR

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2016-04-29