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

Catalog Number 8065977762

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during a cataract surgery with an intraocular lens (iol) implantation, a foreign substance was found on the optic after it was placed into the capsule.The surgeon suspects that the substance on the optic came out from the cartridge when the iol passed through the cartridge.Additional information has been requested.

Manufacturer Narrative

Additional information was provided in h.3., h.6.And h.10.Corrected information was provided in d.10.Evaluation summary: the cartridge was not returned.The cartridge product history records were reviewed and documentation indicated the product met release criteria.The associated lens model is qualified.It is unknown if the lens was in the qualified diopter range for the cartridge.The handpiece and viscoelastic were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.No determination can be made without physical evaluation of the complaint sample.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• 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: 9506237
• MDR Text Key: 177377178
• Report Number: 1119421-2019-02170
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K112977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 8065977762
• Device Lot Number: 32592864
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SN60AT.