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 (1120)

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

Event Date 10/13/2021

Event Type  malfunction  

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).

Event Description

A physician reported that following insertion of the intraocular lens (iol), foreign material was seen in the eye after surgery.The patient had good vision and no problem and did not claim any complaint.As per the surgeon opinion foreign material is likely to be lubricant of the cartridge.Additional information has been requested.

Manufacturer Narrative

The company cartridges were not returned for evaluation.A video was provided.The company lens and cartridge preparation were not shown.The lens was advanced from mid-nozzle into the eye.No foreign material was observed on the lens.Material which appear to be from the capsule edge is visible under the lens toward the bottom.The lens diopter was not provided.It cannot be determined if the lens is qualified without this information.The company toric models are only approved from 6.0 to 25.0 diopters.The root cause for the reported complaint could not be determined.The used company cartridge complaint samples were not returned.No determination can be made without physical evaluation of the complaint sample.The reported foreign material was not observed on review of the provided video.A qualified handpiece and viscoelastic were indicated.It cannot be determined if the lens is qualified without the diopter information.The company toric models are only approved from 6.0 to 25.0 diopters for the company cartridge.Company foldable iols (intraocular lens) 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.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The used company cartridge was not returned for evaluation.Three unopened company cartridges were returned; two for potential lot and 1 for potential lot.One sample was evaluated for each of the potential lot number.The tow unopened company cartridges were opened and microscopically examined with no damage observed.No particulate was observed inside the cartridge lumens.Both of the unopened company cartridges were functionally tested per the dfu (directions for use).No lens or cartridge damage was observed after the lens deliveries.No foreign material was observed.The company cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Two of the unopened company cartridges returned for the potential lot numbers were evaluated.No foreign material was observed.Functional and dye stain testing was conducted with the unopened samples with acceptable results.No foreign material was observed after the functional testing.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been received and stated that, the patient's visual acuity is good and there is no health problem.

• 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: 12826719
• MDR Text Key: 280879351
• Report Number: 1119421-2021-02161
• 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,Followup,Followup,Followup
• Report Date: 02/07/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 01/06/2022; 05/11/2022; 01/10/2023
• Supplement Dates FDA Received: 01/27/2022; 06/04/2022; 02/07/2023
• 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 TRIFOCAL IOL; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Male