NIKON OCULAR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-05 for NIKON OCULAR * manufactured by Nikon.

Event Text Entries

[259390] Pt to undergo laser photo coagulation of the retina, related to neovascular glaucoma. Physician selected lens and performed a pan retinal photocoagulation. Procedure performed on proper eye but wrong site. Pt sustained a scar to the macula, pressure normalized, sight not improved. Pt informed.
Patient Sequence No: 1, Text Type: D, B5

[315903] Add'l info received from mfr on 01/02/03: the medical device (indirect ophthalmoscope) identified in the above-identified medical device report was not manufactured by nikon inc. The device was manufactured by propper manufacturing co. , inc. , 36-04 skillman ave, long island city, new york 11101.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1026107
• MDR Report Key: 415865
• Date Received: 2002-09-05
• Date of Report: 2002-09-05
• Date of Event: 2002-02-19
• Date Added to Maude: 2002-09-13
• 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: 0
• Reporter Occupation: RISK MANAGER
• 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 Sequence Number: 1

• Brand Name: NIKON OCULAR
• Generic Name: INDIRECT OPHTHALMASCOPE
• Product Code: MYC
• Date Received: 2002-09-05
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 404906
• Manufacturer: NIKON
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: VOLK
• Generic Name: INDIRECT OPHTHALMASCOPE
• Product Code: MYC
• Date Received: 2002-09-05
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 404916
• Manufacturer: VOLK
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2002-09-05