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 Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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 two other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a cataract surgery with an intraocular lens (iol) implantation, a scratch was found on the implanted iol.The surgery was completed and the scratched iol remains implanted.According to the reporter the amount of viscoelastic in the cartridge was enough, and there was no problem when setting it up by the skilled nurse.Additional information was provided indicating that there was no potential patient impact.The patient is recovering.The cause of the event is unrelated with no further details provided as to what the reporter is considering the cause.

Manufacturer Narrative

Evaluation summary: the used cartridge was evaluated.Inadequate viscoelastic is observed in the device.The cartridge had evidence it was placed into a handpiece.Light stress is observed at the tip.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results for the presence of top coat.A disruption in the coating is observed on the left side of the cartridge tip.Four unopened samples were also returned for the reported complaint lot.All four returned unopened cartridges were evaluated.The returned unopened cartridges were microscopically examined with no damage observed.No particulate was observed inside the cartridge.The cartridges were functionally tested per the directions for use (dfu) using qualified associated products.No lens or cartridge damage was observed after the lens deliveries.No foreign material was observed.The four cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.A photo was provided of the lens in the eye.There is what appears to be a linear mark or material on the optic.A determination cannot be made from the photo.Product history records were reviewed and documentation indicated the product met release criteria.A qualified lens model and handpiece were indicated.It is unknown if a qualified viscoelastic was used.The root cause for the reported scratched lens could not be determined.The provided photo shows a linear mark or material on the lens.A determination could not be made from the photo.Based on the review of the returned used cartridge, the reported scratch may have been internal coating material from the cartridge tip.The cartridge was damaged.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: 11322621
• MDR Text Key: 233043077
• Report Number: 1119421-2021-00306
• 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
• Report Date: 03/29/2021

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: 32767104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTREPID AUTOSERT IOL INJECTOR, 8065751755; SN60WFA255, ACRYSOF SP NATURAL IQ
• Patient Age: 65 YR