MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR

Model Number III

Device Problem Material Deformation (2976)

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

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the investigation is in progress.A sample is not expected to be received.Based on the preliminary investigation findings, there has been no change in criticality for this complaint.No lot number was identified with this complaint; therefore, a lot history review could not be conducted.A root cause has not been identified.The root cause will be reassessed upon completing the investigation.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that when loading an intraocular lens (iol) prior to the iol implantation procedure, the delivery system has an issue about wrong angle, which lead to haptic deformation.This occurred four times.

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8274035
• MDR Text Key: 134307790
• Report Number: 2523835-2019-00020
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/24/2019

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 Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1