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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Sensation in Eye (1869)

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.The manufacturer internal reference number is: 2019-57636.

Event Description

A health professional reported that multiple patients have experienced residue on implanted intraocular lenses (iol) after surgery.The surgeon is blaming the cartridges.Additional information has been requested.

Manufacturer Narrative

The complaint company iii (d) cartridge samples for lot#: 32683454 were not returned.Ten unopened company iii (d) cartridge samples were returned for the reported lot#: 32683454.All ten returned samples were evaluated.All ten samples were visually inspected and no damage or abnormalities were observed.All ten samples were functionally tested per the dfu using a qualified company iii blue handpiece, company, 27.0 diopter lens and viscoat.No lens or cartridge damage was observed after the lens deliveries.No coating expulsion was observed.No foreign material or residue was observed on the lenses after delivery through the company iii (d) cartridges.All ten cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.No missing material was observed.Company product history records were reviewed and all documents indicate the product met release criteria.A qualified viscoelastic was indicated.The associated lens models were not provided.The diopter range was indicted to be up to 21.5.The root cause for the reported ¿residue¿ cannot be determined.The company iii (d) cartridges used for the surgeries were not returned for evaluation.Ten unused/unopened company iii (d) cartridges for the reported lot#: 32683454 were returned.All ten of the returned unopened company iii (d) cartridges were evaluated.All ten company iii (d) cartridges were visually examined with no abnormalities observed.All ten company iii (d) cartridges were functionally tested per the dfu with no lens or cartridge damage observed.No foreign material or residue was observed on the lenses after delivery.All ten company iii (d) cartridges were top coat dye stain tested with acceptable results.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

Additional information has been received stating the material was a whitish film / deposit around the iol edge / amongst other things under the optics, firmly baked.

• 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: 8861702
• MDR Text Key: 153530331
• Report Number: 1119421-2019-01260
• 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
• Report Date: 09/30/2019

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32683454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 09/13/2019; 09/27/2019
• Supplement Dates FDA Received: 09/19/2019; 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DUOVISC; UNSPECIFIED IOL ACRYSOF