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 Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints in the reported lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported a white foreign material was found in the eye after insertion of the intraocular lens and the cartridge is suspect.The foreign material was removed by washing and aspirating it.The surgery was completed without product replacement.

Manufacturer Narrative

A photo was provided, which showed the returned loose cartridge with three pouch backs and a full pouch.The pouch backs have all been cut off across the bottom.Three lot numbers are pictured.The returned loose cartridge matches the cavity number for the pictured lot.It appears the wrong sample may have been returned or the wrong lot number may have been reported by the facility.The sample was evaluated.A used cartridge was returned.The returned cartridge is a cavity 3 cartridge.This cartridge is not from the reported lot number.There is inadequate viscoelastic observed in the cartridge.The tip is scraped on the upper right side (internal).The cartridge has evidence of placement into a handpiece.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results for the presence of top coat.Damage is observed, to the interior coating with the damaged material still attached.Monarch product history records were reviewed, for the reported and the potential lot number and documentation, indicated the product met release criteria.It is unknown, if the lens was in the qualified diopter range.Other indicated associated products are qualified.Root cause: the root cause for the reported issue could not be determined.Based on the review of the returned used cartridge, the reported foreign material may have been internal coating material from the damaged cartridge tip.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The previous report submitted for this event contained an error, in h.1.¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.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: 11073941
• MDR Text Key: 224413629
• Report Number: 1119421-2020-02031
• 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
• Report Date: 03/18/2021

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: 32747379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/26/2020
• Supplement Dates Manufacturer Received: 02/13/2021; 03/03/2021
• Supplement Dates FDA Received: 03/03/2021; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYST, 8065977773, APD; PROVISC 0.85 OPHTH VISC SUB 1%; SN60WF.XXX, - ACRYSOF SP NATURAL IQ, HWV