FRESHLOOK ONE-DAY CBV92027332

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-02-26 for FRESHLOOK ONE-DAY CBV92027332 manufactured by Ciba Vision Gmbh.

MAUDE Entry Details

• Report Number: 9610813-2020-00002
• MDR Report Key: 9754705
• Report Source: DISTRIBUTOR,FOREIGN
• Date Received: 2020-02-26
• Date of Report: 2020-03-31
• Date Mfgr Received: 2020-03-26
• Device Manufacturer Date: 2015-11-27
• Date Added to Maude: 2020-02-26
• 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: MR. JONATHAN SCHLECH
• Manufacturer Street: 6201 SOUTH FREEWAY MAIL STOP AB2-6
• Manufacturer City: FORT WORTH TX 76134
• Manufacturer Country: US
• Manufacturer Postal: 76134
• Manufacturer Phone: 8175514979
• Manufacturer G1: CIBA VISION GMBH
• Manufacturer Street: POSTFACH, INDUSTRIERING 1
• Manufacturer City: GROSSWALLSTADT D-63868
• Manufacturer Country: GM
• Manufacturer Postal Code: D-63868
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FRESHLOOK ONE-DAY
• Generic Name: LENS, CONTACT, (DISPOSABLE)
• Product Code: MVN
• Date Received: 2020-02-26
• Returned To Mfg: 2020-02-10
• Model Number: NA
• Catalog Number: CBV92027332
• Lot Number: N0635123
• Device Expiration Date: 2019-10-31
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CIBA VISION GMBH
• Manufacturer Address: POSTFACH, INDUSTRIERING 1 GROSSWALLSTADT D-63868 GM D-63868

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-26