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

Model Number III

Device Problem Device Slipped (1584)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported on a note that during an intraocular lens (iol) implant procedure, the lens was placed in the injector and when advanced, the plunger slid over the lens.The doctor was concerned about the iol being scratched and was disposed of.The procedure was completed with a backup lens.There was no patient contact.

Manufacturer Narrative

Final product evaluation: a sample was not received at the manufacturing site for evaluation for the report of plunger when advanced to deploy slid over to iol and scratched lens; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A photo attached to the parent complaint was reviewed by the investigation site.The photo shows three labels with the same product and lot number as reported and a handwriting post-it with the reported event.The reported event cannot be confirmed on the photo attached.Root cause: a sample was not received at the manufacturing site and no lot information was provided; therefore, the root cause for the customer complaint issue cannot be determined.Additional information provided in h.3., h.6.And h.10.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• 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: 9901927
• MDR Text Key: 186750035
• Report Number: 2523835-2020-00075
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• 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
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALON; MONARCH III D CARTRIDGES; SN60WF.185, ACRYSOF SP NATURAL IQ