MAUDE Adverse Event Report: ALCON RESEARCH, LTD./ HUNTINGTON MONARCH III IOL DELIVERY SYSTEM CARTRIDGE -D; LENS GUIDE

Catalog Number 8065977763

Device Problem Defective Device (2588)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 01/29/2015

Event Type  Injury  

Event Description

A healthcare worker reported that during an intraocular lens (iol) implant procedure, a cartridge opened at the tip while inside the eye.This created a hole in the posterior capsule, resulting in an unplanned anterior vitrectomy.Additional info has been requested.

Manufacturer Narrative

Evaluation summary: product history records were reviewed and documentation indicated the product met release criteria.The customer indicated the use of an unapproved lens with the cartridge.The intraocular lens (iol) product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The root cause may be related to a failure to follow the directions for use (dfu).Attempts have been made to obtain additional info.A completed questionnaire was received on (b)(6) 2015.(b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM CARTRIDGE -D
• Type of Device: LENS GUIDE
• Manufacturer (Section D): ALCON RESEARCH, LTD./ HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD./ HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4548640
• MDR Text Key: 5525669
• Report Number: 1119421-2015-00130
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 8065977763
• Device Lot Number: 32329631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR