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 11/20/2019

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.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 manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a cataract extraction with intraocular lens (iol) implant procedure, a foreign material such as a piece of plastic came out in the patient's eye when the iol was implanted.There is a suspicion that it was part of the inside of the cartridge.The surgery was completed.Additional information was provided that the foreign material was found right after inserting the iol in the eye.Only the foreign material was removed and iol was implanted with no problem.

Manufacturer Narrative

Corrected information provided in d.11.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in h.3., h.6., and h.10.Product evaluation: the used cartridge, was returned for evaluation.Viscoelastic was observed in the cartridge.The cartridge has evidence it was placed in a handpiece.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.Review of the provided video shows a clear strip of material on the posterior surface of the optic.The material size and shape are consistent with the damaged interior coating of the returned used cartridge.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 associated lens model and handpiece were not provided.The lens appears to be a single piece.The root cause for the reported complaint could not be determined.Based on the review of the returned used cartridge and the provided video, the reported foreign material was most likely internal coating material from the cartridge tip.It is unknown if a qualified lens model/diopter and viscoelastic were used.The use of non-qualified combinations may result in delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Corrected information provided in h.10.The video review statement has been removed from the product evaluation as it was inadvertently copied to this file.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: 9460984
• MDR Text Key: 176612110
• Report Number: 1119421-2019-02141
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/14/2020

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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 12/22/2019; 03/24/2020; 05/11/2020
• Supplement Dates FDA Received: 01/16/2020; 04/17/2020; 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYST, 8065977773, APD.; UNSPECIFIED IOL.