PUREPOINT LASER 8065750597

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-27 for PUREPOINT LASER 8065750597 manufactured by Alcon Research, Llc - Irvine Technology Center.

MAUDE Entry Details

• Report Number: 2028159-2019-01565
• MDR Report Key: 8937660
• Date Received: 2019-08-27
• Date of Report: 2019-10-14
• Date of Event: 2019-08-05
• Date Mfgr Received: 2019-10-10
• Device Manufacturer Date: 2009-08-06
• Date Added to Maude: 2019-08-27
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. CINDY MILAM
• Manufacturer Street: 6201 SOUTH FREEWAY MAIL STOP AB2-6
• Manufacturer City: FORT WORTH TX 76134
• Manufacturer Country: US
• Manufacturer Postal: 76134
• Manufacturer Phone: 8176152231
• Manufacturer G1: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
• Manufacturer Street: 15800 ALTON PARKWAY
• Manufacturer City: IRVINE CA 92618
• Manufacturer Country: US
• Manufacturer Postal Code: 92618
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PUREPOINT LASER
• Generic Name: LASER, OPHTHALMIC
• Product Code: HQF
• Date Received: 2019-08-27
• Model Number: NA
• Catalog Number: 8065750597
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
• Manufacturer Address: 15800 ALTON PARKWAY IRVINE CA 92618 US 92618

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-08-27