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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/21/2021

Event Type  malfunction  

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, there was a residue on the lenses occurring with all company lenses that are being used through a company cartridge and does not resolve when using different viscoelastic.The reporter guess was that was some sort of oil based material originating in the cartridge.The surgeon states that the residue is on the posterior side of the lens, and is not easy to irrigate/aspirate (i/a) the material off the lens.They have to manually scrape the material off with a metal instrument in order to fully remove it.Another important note is that the residue does not occur when they are using preloaded lenses.

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.A photo was provided for this file.The photo appears to be of a single-piece monofocal lens.What appears to be foreign material is observed on/under the lens.The nature and origin of the material cannot be determined from the photograph.Requested clarification due to similarities.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The company cartridges were not returned for evaluation.A photo was provided of what appears to be a single-piece monofocal lens in the eye.There appears to be a linear strip of foreign material on the posterior surface of the lens.A determination as to the nature and origin of the material cannot be made from the photo.Requested clarification, due to similarities for possible duplicated complaint.Associated products were not provided.It is unknown, if qualified products are being used.The product investigation could not identify a root cause for the reported complaint.The product was not returned for evaluation.No determination can be made without physical evaluation of the complaint sample.A photo was provided.There appears to be a linear strip of material on the posterior surface of the lens.A determination as to the nature and origin of the material cannot be made from the photo.Not enough information was provided, by the reporter for further investigation.It is unknown, if a qualified lens model/diopter, handpiece and viscoelastic were used.Per the ifu (instructions for use): the company delivery system is for implantation of qualified company foldable iols (intraocular lens).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 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).

• 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: 12805338
• MDR Text Key: 280780178
• Report Number: 1119421-2021-02130
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 02/02/2022
• 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: IOL, UNSPECIFIED