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 04/08/2021

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 physician reported that during multiple cataract surgeries with intraocular lens (iol) implantations, foreign material like a piece of transparent fiber was found after insertion.The physician suspects it is something inside the cartridges.Irrigation and aspiration succeeded in removing it and the surgeries were completed without product replacements.This same issue occurred in 5 surgeries on the same day.

Manufacturer Narrative

Additional information was provided in h.3., h.6.And h.10.Evaluation summary: one used cartridge was returned.No residual viscoelastic was observed in the cartridge.The cartridge has evidence it was placed into a handpiece.The tip has stress.An internal disruption in the coating is observed on the roof of the cartridge.This damage starts just before the parting line and extends into the tip.Top coat dye stain testing was conducted with acceptable results for the presence of top coat.Two disruptions along the upper nozzle and tip and one disruption on the lower tip area were observed.A qualified handpiece was indicated.A non-alcon viscoelastic was indicated.The lens model/diopter was not provided.It is unknown if a qualified lens was used.The root cause for the reported issues could not be determined.Only one cartridge was returned.Based on the review of the returned used cartridge, the reported foreign material may have been internal coating material from the damaged cartridge nozzle and tip.The root cause for the observed cartridge damage may be related to a failure to follow the directions for use (dfu).There did not appear to be adequate viscoelastic placed into the cartridge.The dfu instructs to fill the cartridge with viscoelastic before loading 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.It is unknown if a qualified lens was used.The use of non-qualified combinations may result in delivery issues and/or damage.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: 11752203
• MDR Text Key: 248195191
• Report Number: 1119421-2021-00929
• 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: 06/16/2021

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: 15067849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTREPID AUTOSERT IOL HANDPIECE; OPEGAN-HI; INTREPID AUTOSERT IOL HANDPIECE; OPEGAN-HI