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 Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, foreign material deposited into lens optic.The foreign material was removed during the initial procedure with no reported patient harm.Additional information has been requested.

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).

Manufacturer Narrative

Product evaluation: a used cartridge was returned.Viscoelastic is dried in the cartridge.A small aneurysm is observed, on the bottom of the tip in the center.Tip stress was also observed.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The returned specimen cup was sent to the particle lab for evaluation.The solution from the specimen cup was visually and microscopically examined.The contents of the specimen cup were poured into a pre-clean petri dish.Microscopic examination showed a clear natural appearing fiber approximately 730m in length.The clear fiber was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the fibers generated spectra to a library of spectra found the best match to be wypall fibers (paper).Product history records were reviewed and documentation indicated, the product met release criteria.Root cause: the root cause for the reported, foreign material could not be determined.The returned foreign material was evaluated by the particle lab.Microscopic examination showed a clear natural appearing fiber approximately 730m in length.The clear fiber was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the fibers generated spectra to a library of spectra, found the best match to be wypall fibers (paper).The returned cartridge was evaluated.No fibers were observed.Top coat dye stain testing was conducted with acceptable results.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: 11405504
• MDR Text Key: 234480840
• Report Number: 1119421-2021-00465
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2021

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: 15096740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/03/2021; 03/31/2021
• Supplement Dates FDA Received: 03/17/2021; 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC.; INTREPID AUTOSERT.; DUOVISC; INTREPID AUTOSERT
• Patient Age: 83 YR