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 Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The 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.(b)(4).

Event Description

A health professional reported that during an intraocular lens (iol) implant surgery, the surgeon noticed the plate of the implanted lenses has a mark on them in the periphery.There have been no patient impact reported.This report is for multiple cases but the exact number is unknown.Additional information has been requested.

Manufacturer Narrative

Additional information provided in d.11.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The complaint company iii d cartridges were not returned to be evaluated.A total of fifteen company iii d cartridges from the same lot number (32767067) were returned (one unopened carton of ten pouches and one opened carton containing five unopened pouches).Random samples were opened to evaluate.No damage was observed to the test samples.A functional test was conducted per the steps of the dfu using the random samples, approved lens models, approved handpiece and approved viscoelastic.The cartridges were filled with viscoelastic per the dfu.The lenses were loaded and biased down and were advanced forward.The cartridges were each securely placed into the locking slots of the approved handpiece.The lenses were advanced making sure the plunger was in the correct position in contact with the trailing optic edge.The haptic positions were checked at the fill line.The lenses were advanced and delivered through the cartridge in one smooth continuous movement.No lens or cartridge damage was observed after the lens deliveries.The test sample cartridges were cleaned to remove the viscoelastic for further evaluation.A top coat dye stain test was conducted with acceptable results.The company product history records were reviewed documentation indicated the product met release criteria.The specific associated lens models and diopters were not provided.The file indicated lens models included monfocal toric, company lens and company toric.The viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause cannot be determined for the reported issue.The complaint cartridges were not returned.A total of 15 unopened company iii d cartridges from the same lot 32767067 were returned.Random samples were opened to evaluate.No damage was observed.Functional testing was conducted per the steps of the dfu.The lenses delivered through the cartridges with no damage observed to the lenses or to the cartridges.A top coat dye stain test was conducted using the random samples with acceptable results.Information was provided in the file that the complaint cartridges associated lens models included monfocal toric, company lens and company toric.The diopters for these lenses were not provided.Without the diopter, it cannot be confirmed if an approved lens/monarch combination was used.It is unknown if a qualified viscoelastic was used.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Additional information provided h.10.Two viscoelastics were indicated as possibilities.It cannot be determined if a qualified viscoelastic was used.Due to differing material properties, the use of a non-qualified viscoelastic 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: 10619512
• MDR Text Key: 210384343
• Report Number: 1119421-2020-01366
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/05/2020

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: 32767067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 10/20/2020; 10/27/2020; 10/27/2020; 11/04/2020
• Supplement Dates FDA Received: 10/21/2020; 10/27/2020; 10/28/2020; 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(6); DISCOVISC OR PROVISC.; MONARCH CARTRIDGE D.; MONARCH III HANDPIECE.; TFNT00 IOL.