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 Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported foreign material on the surface of the intraocular lens (iol) optic after implantation.Removal of the foreign material was unsuccessful.The iol remains implanted in the eye.The patient will return for follow-up observation.Additional information was received indicating that the surgeon reported that the foreign material floated in the anterior chamber.He indicated that the corneal endothelial cell density decreased from preoperative measurement.A secondary procedure was performed to remove the foreign material.The surgeon believes the foreign material came from the cartridge.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

Further information was received, indicating that visual acuity and endothelial cell density are maintained.

Event Description

Supplemental information was provided by the surgeon indicating that following removal of the foreign material, the iol was checked under mydriatic at outpatient, there was no foreign material present.The most recent corneal endothelial cell measurement was slightly improved however, the surgeon noted that there could be measurement error.

Manufacturer Narrative

The used cartridge was not returned.An unopened cartridge ten-count carton was returned for the reported lot number.The ten returned unopened cartridges were evaluated.All ten were microscopically examined.No foreign material was observed on the cartridges or inside the cartridge lumens.Functional testing was conducted per the dfu with qualified associated products.No lens or cartridge damage was observed.No foreign material was observed on the lenses after delivery.The cartridges were dye stained with acceptable results.A photo and two videos were provided.The first video is the lens implant.The cartridge and lens preparation were not shown.The lens loading was not shown.The lens was rapidly delivered.An elongated foreign material was observed the right side of the posterior surface.The material was not removed and the lens remained implanted.The second video showed a foreign material floating in the eye.The video did not show the removal of the material.The provided photo is of the material observed in the second video.A particle was returned, which was indicated to be the foreign material removed from the eye.The returned particle was evaluated.The particle is a flexible plastic-type material.It has the appearance that was torn from a larger source.There are overlapped edges and folds.There are also straight edges and a long narrow strip on one side.The sample was sent to particle lab for identification testing.The clear material was isolated and analyzed.Comparison of the clear material's generated ir spectra to a library of spectra finds the best match to be polypropylene.Ft-ir scans and photos of the returned particle were reviewed.The origin of the polypropylene material cannot be determined.Monarch product history records were reviewed and documentation indicated the product met release criteria.The indicated lens is not qualified for use with the cartridge.The indicated handpiece and viscoelastic are qualified.A root cause could not be determined for the returned foreign material.The clear material was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the clear material's generated ir spectra to a library of spectra finds the best match to be polypropylene.The used cartridge was not returned for evaluation.Physical evaluation of the used cartridge would be necessary to make a root cause determination.The indicated associated iol is not qualified for use in the cartridge.The use of non-qualified combinations may lead to delivery issues and/or damage to the lens or the cartridge ten unopened cartridges were returned for the reported lot number.Microscopic examination of each cartridge revealed no foreign material or damage.Functional testing of the ten returned unused cartridges resulted in no damage and no foreign material.The investigation did not identify any sources of loose polypropylene particles in manufacturing.¿ all monarch cartridges receive a high-pressure air blow-off on a downdraft table, when initially loaded into inserts ¿ before coating, as the product enters the coating machine, each insert is blown off with a deionized air knife.¿ at final cosmetic inspection, an individual high-pressure air blow-off is utilized.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: 10977985
• MDR Text Key: 220531172
• Report Number: 1119421-2020-01885
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 15008304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Manufacturer Received: 11/22/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 02/05/2021; 03/05/2021
• Supplement Dates FDA Received: 02/24/2021; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF TORIC IOL; MONARCH IOL DELIVERY SYSTEM; PROVISC; ACRYSOF TORIC IOL; MONARCH IOL DELIVERY SYSTEM; PROVISC
• Patient Outcome(s): Required Intervention