MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977763

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that a couple of doctors have noted that when they use cartridges during intraocular lens (iol) implant procedures there seems to be a strip that comes off and ends up in the eye.Both doctors have noted that the strip is quite difficult to remove from the eye and that it seems to be firm and plastic like.Additional information was provided that the event happens when the cartridge is used with a competitors iol and or a competitors toric iol.We have used these cartridges with these lenses in the past with no issue.The procedures were completed.The plastic piece that was in the eye after lens insertion was removed by irrigation / aspiration and or removed with a forcep.The event has occurred with multiple patients.No harm and the iols remained intact.There are three medical device reports associated with the cartridges reported.This report is for one of three lot numbers reported with an unknown date of event.

Manufacturer Narrative

Evaluation summary: the customer indicated the use of non-qualified associated products.The root cause is most likely a failure to follow the directions for use (dfu).The account used a non-qualified lens/cartridge combination.The use of non-qualified combinations may result in delivery issues and/or damage.Customer has indicated the use of different manufacturer's iols.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 9105671
• MDR Text Key: 165635881
• Report Number: 1119421-2019-01551
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32683471
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT MEDICAL OPTICS IOL AND OR TORIC IOL; HEALON GV; MONARCH II LOADING; UNSPECIFIED ALCON HANDPIECE; UNSPECIFIED DISCOVISC; UNSPECIFIED PROVISC