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 11/18/2020

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.(b)(4).

Event Description

A facility representative reported that during a cataract surgery with an intraocular lens (iol) implantation, a lint fiber was found to be adhered to the underside of the lens when the lens unfolded after insertion.The surgeon was able to remove the fiber strand and the lens remains implanted in the patient with no reported harm.

Manufacturer Narrative

Evaluation summary: a cartridge was returned in an opened pouch.Inadequate viscoelastic is observed in the cartridge.Damage was observed to the upper interior tip.This damage was diagonal (side to side) with in inward path.It appears that this may have been cause by something inserted from the tip of the cartridge.The damage is not is consistent with damage that may occur during a lens advancement or delivery, which would have a travel path of front to back (toward the end of the tip).Top coat dye stain testing was conducted with acceptable results.Two photos were provided.The first photo is of a lens in the eye with an instrument under the lens.There appears to be something in front of the instrument tip.The second photo is a magnified photo of a lens in the eye.There are dark areas observed, which may be the reported "lint".No determination can be made from the provided photos.Product history records were reviewed and documentation indicated the product met release criteria.A fiber was returned with the cartridge.The particle lab evaluated the returned fiber.The root cause for the reported ¿lint¿ could not be determined.Microscopic examination showed a natural appearing blue fiber.This is not a product used during the manufacturing of cartridges.The origin of the blue fiber is unknown.It is unclear if this was the material, which was removed from the eye.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: 11045943
• MDR Text Key: 223169849
• Report Number: 1119421-2020-01976
• 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: company representative,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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: 15082093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CUSTOM PAK, HTX