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 Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, it was reported that there was a resistance while implanting a high power iol.The iol was implanted without problems after replacing the cartridge with another one.Additional information was provided that 2 cartridges were returned but it was unknown which one was actually used, and it was also unknown which lot the used cartridge belongs to.Usb containing surgical video will be also returned.

Manufacturer Narrative

The used company cartridge was not returned for evaluation.A video was provided.The lens loading was shown.Viscoelastic was observed only placed at the loading area entrance of the cartridge.This was an inadequate amount.Only part of the lens loading could be observed as the cartridge was moved below the frame.The lens was rapidly advanced with the forceps to the nozzle entry area.The cartridge was removed from view and returned loaded into a company handpiece.The lens and haptic positions appeared acceptable.The nozzle tip was placed into the incision.The lens was advanced into the tip.The cartridge was removed from the incision.The cartridge came back into view with lens slightly exiting the tip.The plunger had been retracted.A possible split tip or aneurysm was observed bottom left.Unable to determine from the video.The second implant attempt was successful.The second attempt was at a slower rate.The lens was delivered and positioned with a suture placed.No wound widening was observed during the implant attempts.Qualified associated products were indicated.Based on review of the provided video the cause for the reported resistance may be related to a failure to follow the instructions for use (ifu).Viscoelastic was observed placed only at the loading area entrance.The cartridge tip appeared to be damaged as the lens was advanced.The ifu instructs to completely fill the cartridge with ovd (diagram provided) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in 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: 12373694
• MDR Text Key: 268346951
• Report Number: 1119421-2021-01646
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

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 Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 10/05/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ NATURAL SINGLEPIECE IOL; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; ACRYSOF IQ NATURAL SINGLEPIECE IOL; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE