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

Model Number ASKU

Device Problems Entrapment of Device (1212); Scratched Material (3020)

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

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The complaint history and 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.Based on the preliminary investigation findings, there has been no change in criticality for this complaint.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the injector was stuck while the iol was in the wound.The iol was not scratched.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: a sample was not received at the manufacturing site for evaluation for the report of injector stuck while iol in the wound; therefore, the condition of the product could not be verified.The root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• MDR Report Key: 9802210
• MDR Text Key: 185610417
• Report Number: 2523835-2020-00057
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUCKWORTH AND KENT INJECTOR; FCI PROTECT VISCOELASTIC; UNSPECIFIED IOL