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 Problems Contamination /Decontamination Problem (2895); Mechanical Jam (2983)

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

Event Date 06/30/2020

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

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, some white thread or powder-like plastic material is coming out of cartridge and getting stuck on iol.Additional information was requested.

Manufacturer Narrative

Product evaluation: the cartridge was not returned for evaluation.Two videos were provided.A "still" photo was provided from the second video.Review of the videos was inconclusive.Neither video showed the lens/cartridge preparation or the lens advancement/delivery.The videos only showed the lens already implanted.The different videos showed two different materials.Both appeared to be under the lenses.One closely resembled a fiber (long, thin, white appearance).The second material appeared thinner and loose.A magnified photo was provided with a red arrow indicator.Due to the clarity of the photo it cannot be determined if this is a foreign material or damage.It cannot be determined if it is on or under the lens.Product history records were reviewed and documentation indicated the product met release criteria.Associated products 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 video/photo evaluation was inconclusive.The two "materials" observed did to appear similar in nature.Removal of the material was not shown.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: 10303295
• MDR Text Key: 200611547
• Report Number: 1119421-2020-01028
• 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
• Report Date: 09/25/2020

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: 07/31/2020
• Device Catalogue Number: 8065977763
• Device Lot Number: 32398684
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 09/07/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED IOL