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 Peeled/Delaminated (1454); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

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 are three similar complaints reported in the lot number.(b)(4).

Event Description

A facility representative reported that foreign material was found adhered to the back surface of the intraocular lens after implantation into the eye.The foreign material was able to be aspirated and removed by irrigation aspiration.The surgery was completed without product replacement or patient harm.It was noted that the coating agent inside the cartridge might have peeled off onto the intraocular lens.Additional information requested.There are four medical device reports associated with cartridges for the same doctor on the same day.This report is associated with the fourth cartridge.

Manufacturer Narrative

The cartridge was not returned for evaluation.A video was provided.The lens was loaded before the cataract surgery.Inadequate viscoelastic was placed into the cartridge.Viscoelastic was added just at the loading area.The lens is loaded with what appear to be loading forceps.The cartridge returns to view after the cataract removal.The lens is visible just inside the nozzle entry area, not at the fill line.The tip is inserted into the incision.The lens is quickly advanced into the eye from the nozzle entry area.After the lens unfolds, a strip of material is observed on the right side of the posterior surface.The material was removed with the irrigation/aspiration tip.The lens remains implanted.The product history records were reviewed and documentation indicated the product met release criteria.The lens/model diopter indicated is qualified for use with the cartridge.A non-qualified handpiece/viscoelastic combination was indicated.The root cause for the reported foreign material could not be determined.The used cartridge was not returned.No determination can be made without physical evaluation of the complaint sample.The provided video was reviewed.Inadequate viscoelastic was placed into the cartridge.The directions for use (dfu) 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.Material was observed on the lens.Based on the review of the provided video, the observed material may have been internal coating material from the cartridge.A non-qualified handpiece/viscoelastic combination was indicated.Although the root cause has not been determined, contributing factors could be: a.Viscoelastic type: the use of a non-qualified viscoelastic may result in delivery issues and/or damage.B.Viscoelastic amount: not using the appropriate amount of viscoelastic as described in the dfu may result in delivery issues and/or damage.C.Non-qualified handpiece: the use of non-qualified handpiece 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: 10613405
• MDR Text Key: 209644328
• Report Number: 1119421-2020-01360
• 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: 10/22/2020

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?: Yes
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AE-9063CSP; HEALON; SN60WFA245