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 Scratched Material (3020)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

A sample device 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 reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A director reported that scratches on the backside of intraocular lenses (iol's) were observed with six patent's following iol implantation.Additional information has been requested.

Manufacturer Narrative

Product evaluation: six used cartridge samples for the same lot were returned and visually examined.There appeared to be inadequate viscoelastic in all six cartridges.All six had evidence of being placed into the handpiece.No damage or abnormalities were observed.Typical evidence of a lens delivery was not observed.The cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The lenses were not returned.Cartridge product history records were reviewed and documentation indicated the product met release criteria.The lens model/diopter, handpiece and viscoelastic used were not provided.The root cause for the reported scratched lenses could not be determined.The lenses were not returned for evaluation.It is unknown if qualified associated product were used as this information was not provided.The six returned cartridges were evaluated.No damage was observed.The cartridges were dye stain tested with acceptable results.All six cartridges appeared to exhibit an inadequate amount of viscoelastic.This may have been a contributing factor.Not adequately filling the cartridge with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage or delivery issues.Additional information provided in d.10., h.3., h.6.And h.10.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: 8719449
• MDR Text Key: 148823002
• Report Number: 1119421-2019-00967
• 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
• Report Date: 01/14/2020

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 Expiration Date: 08/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32654026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1