BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-08-16 for BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENS manufactured by Bausch & Lomb Incorporated.

MAUDE Entry Details

• Report Number: 0001313525-2019-00125
• MDR Report Key: 8902039
• Report Source: CONSUMER,HEALTH PROFESSIONAL
• Date Received: 2019-08-16
• Date of Report: 2019-04-29
• Date of Event: 2019-03-30
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2019-09-05
• Device Manufacturer Date: 2018-09-16
• Date Added to Maude: 2019-08-16
• 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: 3
• Manufacturer Contact: MS. JENNIFER GAMET
• Manufacturer Street: 1400 NORTH GOODMAN STREET
• Manufacturer City: ROCHESTER NY 14609
• Manufacturer Country: US
• Manufacturer Postal: 14609
• Manufacturer Phone: 5853386853
• Manufacturer G1: BAUSCH + LOMB
• Manufacturer Street: UNIT 424/425, CORK ROAD INDUSTRIAL ESTATE
• Manufacturer City: WATERFORD
• Manufacturer Country: EI
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENS
• Generic Name: LENS, CONTACT, DISPOSABLE
• Product Code: MVN
• Date Received: 2019-08-16
• Lot Number: W87237333
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAUSCH & LOMB INCORPORATED
• Manufacturer Address: 1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US 14609

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-08-16