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 Problem Material Separation (1562)

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

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: cartridge complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There has been one other complaint reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported following the implant of an intraocular lens (iol), there was a film that seemed to have separated from the cartridge.This film has adhered to the lens and is currently implanted and is not affecting the patient.Additional information was requested.

Manufacturer Narrative

The company iii (d) cartridge was not returned for evaluation.Product history records were reviewed and documentation indicated the product met release criteria.The indicated iol is qualified for use with the company iii (d) cartridge.The viscoelastic indicated is qualified with the lens/cartridge combination used.A non-company handpiece was indicated, which is not qualified for use with company cartridges.The product investigation could not identify a root cause.The company iii (d) cartridge was not returned for evaluation.Information was provided that a non-qualified handpiece was used.The use of non-qualified combinations may result in delivery issues and/or damage.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: 9930821
• MDR Text Key: 187482726
• Report Number: 1119421-2020-00636
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 8065977763
• Device Lot Number: 32705435
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ..; PROVISC; SN60WF.235
• Patient Age: 68 YR