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 /Decontamination Problem (2895)

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

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A surgeon reported that during a cataract surgery with an intraocular lens (iol) implantation, "foreign material was found to be adhered to the back side of iol after implanting." the foreign material was able to be removed and the iol remains implanted with no reported harm to the patient.The same event occurred within five eyes.This case is related to the first eye.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the used cartridge was returned for evaluation.Inadequate viscoelastic was observed in the cartridge.The cartridge has evidence it was placed in a handpiece.The cartridge was cleaned for further evaluation.Topcoat dye stain testing was conducted with acceptable results for the presence of topcoat.Damage was observed to the interior coating on the right side of the tip (disruption in the coating) of the used cartridge.The associated lens model/diopter indicated is qualified for use with the cartridge.The associated handpiece/viscoelastic combination is not a qualified combination.Based on the review of the returned used cartridge, the reported foreign material may have been internal coating material from the cartridge tip.There did not appear to be adequate viscoelastic in the device.The directions for use instructs to fill the cartridge with viscoelastic before attempting to load the lens.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with viscoelastic, which may result in damage or delivery issues.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: 10604203
• MDR Text Key: 209350165
• Report Number: 1119421-2020-01348
• Device Sequence Number: 1
• Product Code: MSS
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

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 Catalogue Number: 8065977763
• Device Lot Number: 32751148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AE-9036SP; OPEGAN; SN60WFA175