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 Device Contamination with Chemical or Other Material (2944)

Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937); Iritis (1940); Blurred Vision (2137)

Event Date 12/27/2022

Event Type  Injury  

Event Description

A non-health care professional reported during the intraocular lens implantation noticed a white milky/chalky substance (white dust/cloud of material) coming out of the cartridge tips while implanting and the pattern continued fir several cases after which it was noticed that the cartridges had expired in 2016.The integrity of the packaging weren¿t compromised.Additional information has been requested and received stating the product did not cause or contribute to the event.Cause of event is having expired product on hand and oversight of expiration during opening of packages in or.The white material represents some breakdown product of these long- expired cartridges.There was no harm to the patient, no medical or surgical intervention was need as a result of the event.The procedure was completed on the same day.The cartridge was filled with the viscoelastic at room temperature.It was also reported that this issue involve 7 patients.Six of them looked just fine on postoperative day one.One had an elevated iop of 27, which also occurred on his first eye surgery.He had significant corneal edema and blurred vision.Additional information was received stating the vision of all the patients was good at 20/25 or better.But one patient was at 20/30.One patient had intraocular pressure rise to 27mmhg that patient was a glaucoma suspect with cups of 0.5 and 0.6 preop with normal iop preop.His anterior chamber and his vision was 20/20 uncorrected and put him on timolol.So far the patients were all looking good.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Two photo were provided.The first photo shows the video screen.An eye is visible.A single-piece toric lens is visible in the eye.Various elongated artifacts are observed.One area has the appearance of a scratch.Other areas are observed, which may be particles or biologic material in the eye.No determination can be made from the photo.The second photo shows a single-piece multifocal iol in the eye.Focus is on the eyelashes and not on the iol.Unable to visualize reported material.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided h.3., h6., and h.10.The reporting facility used company cartridges which expired 12-31-2016 to implant the lenses.The facility verified the expiration date after issues were noted.The instructions for use (ifu) instructs: expiration date - sterility is guaranteed until the use-by date unless the primary sterilization package is damaged or opened.The use-by date is clearly indicated on the outer box label of the carton.Any cartridge held after the use-by date should not be used.Product history and shipping records were reviewed.The company cartridge was manufactured 25-jan-2012.Records show that the product was shipped in february and march of 2012.The company cartridge expired 31-dec-2016.It cannot be determined how the reporting site had product manufactured and shipped in 2012, that expired in 2016.Shipping records for the reporting facility encompassing 01-01-2022 to 12-31-2022 were reviewed.All product shipped to the facility in the last 12 months was current product.Global quality customer affairs has corresponded with the surgeon regarding the issue.All patient¿s were reported to be doing well.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16233370
• MDR Text Key: 308003803
• Report Number: 1119421-2023-00196
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 8065977763
• Device Lot Number: 32122939
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2022
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COMPANY FORCEPS; MONARCH III IOL INJECTOR; ORA SYSTEM WITH VERIFEYE MESSAGING; PROVISC; TIMOLOL
• Patient Outcome(s): Other