EYE GLASSES ALTAIR 710 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-10 for EYE GLASSES ALTAIR 710 * manufactured by Altair Eyewear.

Event Text Entries

[17431399] Dr was out jogging after dark and fell, breaking his glasses. The lenses were fine, but the plastic frames shattered, creating a jagged edge from the nose piece which penetrated the bridge of his nose, barely missing his eye.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1010696
• MDR Report Key: 67665
• Date Received: 1997-02-10
• Date of Report: 1997-02-10
• Date of Event: 1997-02-06
• Date Added to Maude: 1997-02-12
• 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: 0
• 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: EYE GLASSES
• Generic Name: EYE GLASSES
• Product Code: HQZ
• Date Received: 1997-02-10
• Model Number: ALTAIR 710
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 67679
• Manufacturer: ALTAIR EYEWEAR
• Manufacturer Address: 10395 OLD PLACERVILLE RD SACRAMENTO CA 95827 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-02-10