MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH IOL DELIVERY SYSTEM, CARTRIDGE; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number ASKU

Device Problem Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

An other health care professional reported that during intraocular lens (iol) implantation procedures, the doctor has frequently encountered many cases of lens scratches.Additional information was received.The doctor himself thinks that the lens scratches might be due to the inside of the cartridge.According to the additional information, the reporter was not sure whether it was a scratch or a temporary dent in the lens, it seemed more like a temporary dent in the lens than a scratch.The lens remains inside the eye.Additional information was received.The scratch was found on the anterior side of the optic.The lens folding went well.According to the reporter perhaps there was a very small burr or crystal on the forceps on the underside of the thin upper leg, (which touches the optic when pushing the iol down) that caused the scratch on lens.However, the scrub nurse could not yet explain this because the forceps were pulled back against the roof of the cartridge, so that this does not scrape the optics.The doctor indicated that the scratch was immediately visible when the iol was still unfolding in the eye, so immediately upon insertion.It seemed on the photos as if the scratch was always present on the trailing haptic, though it could not be entirely said, as the surgeon sometimes rotates the iol during the procedure.The reporter also reported that the iol was sometimes loaded a little early, but had not seen that the dwell time was more that 3 minutes.According to the reporter the dwell time could not be an issue, because the haptics and iol were nicely folded and there was no stretched haptic.The customer had no idea what caused the incident, but speculated it might be the forceps.Everything went smoothly with the lens folding, procedure, and temperature.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A photo was provided of a single piece multifocal toric lens in the eye.A mark was observed in the center of the lens.Unable to determine if posterior or anterior; possibly posterior.No determination can be made from the photo for the cause of the mark.A qualified handpiece was indicated.The lens model/diopter and viscoelastic were not provided.It is unknown if a qualified lens and viscoelastic were used.The product investigation could not identify a root cause for the reported complaint.The product was not returned.A determination cannot be made without physical examination of the product.No determination can be made from the photo for the cause of the mark.Not enough information was provided for further investigation.It is unknown if a qualified lens and viscoelastic were used.The instructions for use (ifu) instructs: the company intraocular lens (iol) delivery system is for implantation of qualified company foldable iols.No unqualified lenses should be used with the company iol delivery system.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 a 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.Use the company cartridge at operating room temperatures between 18° c (64° f) and 23° c (73° f).The ifu instructs to completely fill the cartridge with an 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.File will be reopened if new information is received.The training group was made aware of the complaints.Refresher training was conducted for the or personnel regarding loading the iols with respect to proper use of forceps and injector.Both injectors and forceps were replaced.This is being monitored closely.Visits will be conducted to follow up on the retraining.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH IOL DELIVERY SYSTEM, CARTRIDGE
• 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: 18157051
• MDR Text Key: 328359294
• Report Number: 1119421-2023-01918
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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 Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; UNSPECIFIED DELIVERY SYSTEM