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

Catalog Number	8065977763
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been three other complaints reported in the lot number by the same facility.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, a white plastic like string was left on the iol after the lens was inserted.The material was removed with no patient harm and the case was completed.The doctor suggested the foreign material could be caused by the cartridge.Additional information was requested.
Additional Manufacturer Narrative
Three company cartridges were returned; one opened/not used and two unopened.This lot is related to four files.Evaluation will be placed in all four files.The opened company cartridge was microscopically examined.No damage or foreign material was observed.One of the unopened company cartridges was opened and evaluated.The unopened cartridge was microscopically examined.No damage or foreign material was observed.The returned unopened company cartridge was functionally evaluated.No lens or cartridge damage was observed after the lens delivery.No foreign material was observed.The returned unopened company cartridge was cleaned for further evaluation.Top coat due stain testing was conducted with acceptable results.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The lens model/diopter and handpiece information was not provided.It is unknown if qualified products were used.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.One company cartridge returned for the reported lot was 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 lens model/diopter and handpiece information was not provided.It is unknown if qualified products were used.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11624495
• Report Number: 1119421-2021-00752
• Device Sequence Number: 4468078
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 380659777639
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2025
• Device Catalogue Number: 8065977763
• Device Lot Number: 15090259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM; UNKNOWN IOL