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 Particulates (1451)

Patient Problem Insufficient Information (4580)

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

An opened, 10-count company cartridge carton for reported lot was returned.The carton contained three used company cartridges in a bag and two unopened company cartridges.The used cartridges are for three files.It cannot be determined which returned used company cartridge belongs to each pr.The evaluation will be placed in all three files.A video was provided.The cataract removal was shown.The company cartridge and lens preparation were not shown.The company cartridge was brought into view with the lens already inserted into the loading area.The trailing haptic was folded in and the lens was rapidly advanced.The cartridge was brought back into with the lens advanced to mid-nozzle.The cartridge tip was inserted with the aid of forceps at the incision.The lens was rapidly advanced into the eye.There was a slight override of the optic, impression visible from the plunger tip.As the lens was positioned with an instrument, a linear material was visible which appeared to be on the posterior surface.The i/a tip was used to remove the material without issue.The lens remains implanted.The three loose company cartridges were numbered 1-3 for evaluation purposes.The company cartridges were microscopically examined.Cartridges #1 and #2 had viscoelastic observed.Both of these had tip stress and internal damage on the left side.Cartridge #3 had no viscoelastic.The cartridge did not have evidence of placement into a handpiece.No damage was observed.All three returned loose company cartridge were cleaned for further evaluation.All three met specification for the presence of top coat.Cartridges #1 and #2 had internal damage with disruption in the coating on the left side of the tip.One of the returned company cartridges was opened and microscopically examined with no damage observed.No particulate was observed inside the cartridge lumen.The company cartridge was functionally tested per the ifu.No lens or cartridge damage was observed after the lens delivery.No foreign material was observed.The company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.A qualified lens/model diopter was indicated with a non-qualified handpiece and viscoelastic.The root cause for the reported issue could not be determined.Review of the video showed a slight override of the optic, impression visible from the plunger tip.Based on the review of the video and the returned used company cartridges, the reported foreign material may have been internal coating material from the damaged company cartridge tip.Two of the returned loose cartridges were damaged.The third cartridge was not damaged and did not show signs of use.One of the returned unopened company cartridges was opened and microscopically examined with no damage observed.No particulate was observed inside the cartridge lumen.The company cartridge was functionally tested per the ifu.No lens or cartridge damage was observed after the lens delivery.No foreign material was observed.Pert the ifu: the company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.It could not be determined if adequate viscoelastic was used.The ifu also instructs to completely fill the cartridge with ovd 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).

Event Description

A physician reported that during implantation of intraocular lens procedure, an adhered material like a straight thread-like foreign material was noted on the posterior surface of the iol in the eye after the implant, and it was removed by aspirating the posterior surface with irrigation/aspiration.The physician suspects that the coating inside the cartridge was peeled off.There are three medical device reports associated with this event.This is 2 of 3.

• 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: 17478216
• MDR Text Key: 320575801
• Report Number: 1119421-2023-01408
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• 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: 15097715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASICO INJECTOR: AE-9063CSP; CLAREON IOL; OVD: HEALON