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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-02 for * manufactured by Systems Of Sight.

Event Text Entries

[347703] The firm, systems of sight, inc. Is dealing in eye glasses that are advertised to improve the vision of people with macular degeneration, optic nerve damage or similar low vision problems. There is no 510k for this device. Manufacturer claims that the glasses offer improved sight for people with low vision problems such as macular degeneration, optic nerve damage or the like. The improved glasses comprise a lens assembly having a magnifying lens for converging received light and a reducing lens for diverging received light and a frame for supporting the lens assembly at a predetermined distance from an eye of a user and for supporting the lens in a predetermined orientation with respect to each other with the lenses defining a space there between along the optical axes of the lens. From speaking to one complainant the state believes these claims to be false and is searching for add'l consumers of this product.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003872
• MDR Report Key: 570551
• Date Received: 2005-02-02
• Date of Report: 2004-10-27
• Date Added to Maude: 2005-02-08
• 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: 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: *
• Generic Name: EYE GLASSES
• Product Code: HOI
• Date Received: 2005-02-02
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 560399
• Manufacturer: SYSTEMS OF SIGHT
• Manufacturer Address: * * US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-02-02