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 Crack (1135); Product Quality Problem (1506); Use of Device Problem (1670); Scratched Material (3020)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.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 facility representative reported dissatisfaction due to scratched cartridges after intraocular lens (iol) implantation.The scratches are noted in the cartridges with the use of aspherical, spherical, and trifocal lenses.To discard the possibility of damaged caused by the injector, they injector was exchanged but the problem persisted.Other doctors in the same entity noted scratched cartridges but with lesser intensity.Additional information received stated that the cartridge was more narrow compared to the same model of another lot, when it was used, presented cracks in the tip.

Manufacturer Narrative

The product was not returned.Three photos were provided.The cartridge views are from the bottom and the side and one from the top.Photos 1-2 show the cartridges held with an ungloved hand.There appears to be minimal viscoelastic in these 2 cartridges.The nozzle and tip are cracked.The damage is from mid-nozzle into the tip (bottom right).The tip also has the appearance of heavy stress.Due to the quality of the photos it cannot be determined if the tips are also split.Photo 3 is of a cartridge laying on its side, tip up.Due to glare on the tip, damage cannot be visualized.The root cause may be related to a failure to follow the dfu.Based on review of the provided photos the cartridges were cracked.The damage on the nozzle started in the thick wall cone area.Unusually high internal forces would be needed to create damage in this area.The damage would indicate a progressive change that occurred as the lens was advanced.Damage in the thick cone wall section has been associated with the use of cold viscoelastic.This type of damage may also occur if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; if the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge.If the handpiece plunger is not positioned at the trailing optic edge, it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens.There did not appear to be an adequate amount of viscoelastic in the cartridge, but his cannot be verified from a photo.The dfu instructs to fill the cartridge with viscoelastic before loading the lens.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 or delivery issues.A non-qualified viscoelastic was indicted.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.It is unknown if a qualified lens model/diopter and handpiece are being used.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: 11124893
• MDR Text Key: 226640919
• Report Number: 1119421-2021-00031
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

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: 32762503
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 02/27/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1