MAUDE Adverse Event Report: ALCON MONARCH III D CARTRIDGE

Model Number 8065977763

Device Problems Split (2537); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2017

Event Type  malfunction  

Event Description

Alcon monarch iii "d" cartridge, product # 8065977763, lot # 32519287, exp 2021-12, noted to split as well as torn haptic off lens.

• Brand Name: MONARCH III D CARTRIDGE
• Type of Device: MONARCH III D CARTRIDGE
• Manufacturer (Section D): ALCON
• MDR Report Key: 6489388
• MDR Text Key: 72840576
• Report Number: MW5069062
• Device Sequence Number: 1
• Product Code: KYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 8065977763
• Device Catalogue Number: 10-800-118-001
• Device Lot Number: 32519287
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1