STRATUS OCT 3000 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-02-26 for STRATUS OCT 3000 NA manufactured by Carl Zeiss Meditec Inc.

Event Text Entries

[337525] A pt experienced an electrostatic discharge while taking an exam. The discharge occurred in the vicinity of the pt's eye.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2918630-2004-00002
• MDR Report Key: 528643
• Report Source: 05,06
• Date Received: 2004-02-26
• Date of Report: 2004-02-25
• Date of Event: 2004-02-09
• Date Mfgr Received: 2004-02-11
• Device Manufacturer Date: 2002-07-01
• Date Added to Maude: 2004-06-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Manufacturer Street: 5160 HACIENDA DRIVE
• Manufacturer City: DUBLIN CA 94568
• Manufacturer Country: US
• Manufacturer Postal: 94568
• Manufacturer Phone: 9255574353
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STRATUS OCT
• Generic Name: OPTICAL CORNEAL TOMOGRAPHER
• Product Code: HLI
• Date Received: 2004-02-26
• Model Number: 3000
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 517834
• Manufacturer: CARL ZEISS MEDITEC INC
• Manufacturer Address: * DUBLIN CA * US
• Baseline Brand Name: STRATUS OCT
• Baseline Generic Name: OPTICAL CORNEAL TOMOGRAPHY
• Baseline Model No: 3000
• Baseline Catalog No: 00203-01
• Baseline Device Family: OCT
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K030433
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-02-26