MILLENNIUM PHACOEMULSIFICATION HANDPIECE CX7000

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 2006-09-19 for MILLENNIUM PHACOEMULSIFICATION HANDPIECE CX7000 manufactured by Bausch & Lomb, Inc..

Event Text Entries

[20510984] The patient received a corneal burn, during a cataract extraction procedure. Stitches were used to close the wound.
Patient Sequence No: 1, Text Type: D, B5

[20827960] This form has been completed by the manufacturer.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1920664-2006-01192
• MDR Report Key: 763329
• Report Source: 05,06
• Date Received: 2006-09-19
• Date of Report: 2006-09-05
• Date of Event: 2006-09-01
• Device Manufacturer Date: 2004-03-01
• Date Added to Maude: 2006-09-25
• 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 Contact: JANET LACAVICH
• Manufacturer Street: 3365 TREE COURT INDUSTL BLVD
• Manufacturer City: ST. LOUIS MO 63122
• Manufacturer Country: US
• Manufacturer Postal: 63122
• Manufacturer Phone: 6362263213
• 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: MILLENNIUM PHACOEMULSIFICATION HANDPIECE
• Generic Name: PHACOEMULSIFICATION HANDPIECE
• Product Code: MUS
• Date Received: 2006-09-19
• Model Number: NA
• Catalog Number: CX7000
• Lot Number: NA
• ID Number: NA
• Device Expiration Date: 2009-03-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 751223
• Manufacturer: BAUSCH & LOMB, INC.
• Manufacturer Address: * ROCHESTER NY 14609 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2006-09-19