OPTO PULSE 100 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-28 for OPTO PULSE 100 * manufactured by Optogon.

Event Text Entries

[330923] Bought a stimulator device from www. Optogon. Com which they said could treat stargarts disease. Spoke with two people from the macular degeneration foundation, who said device was safe and fda approved. Eye dr says the device is no way approved. Reporter's eyesight is getting worse after using it, and they think the thing hurt them.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1029994
• MDR Report Key: 493725
• Date Received: 2003-10-28
• Date of Report: 2003-10-28
• Date of Event: 2003-06-01
• Date Added to Maude: 2003-11-06
• 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
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OPTO PULSE 100
• Generic Name: EYE STIMULATOR
• Product Code: NCI
• Date Received: 2003-10-28
• Model Number: 100
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 482430
• Manufacturer: OPTOGON
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-10-28