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 Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a cataract surgery with an intraocular lens (iol) implantation, foreign material was seen floating or sticking on the back of the iol after insertion.The surgery was completed after removing the foreign material.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the used cartridge complaint sample was not returned.Nine loose unopened cartridges and one unopened 10-count carton from the reported lot# were returned.One unopened cartridge was pulled from each group.The unopened cartridges were numbered 1-2 for evaluation purposes.The unopened cartridges were microscopically examined.No damage or foreign material was observed.The returned unopened cartridges were functionally evaluated.No lens or cartridge damage was observed after the lens deliveries.No foreign material was observed.The returned unopened cartridges were 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.A qualified lens model was indicated.It is unknown if the lens was in the qualified diopter range.A qualified handpiece and viscoelastic were indicated.The root cause for the reported complaint could not be determined.The used cartridge complaint samples were not returned.No determination can be made without physical evaluation of the complaint sample.Two of the unopened cartridges returned for the reported lot were evaluated.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).

• 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: 11870417
• MDR Text Key: 252188754
• Report Number: 1119421-2021-01078
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• 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
• Report Date: 07/09/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 15094023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/24/2021
• Supplement Dates Manufacturer Received: 06/24/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ TORIC SINGLEPIECE IOL; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; ACRYSOF IQ TORIC SINGLEPIECE IOL; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE