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 Problems Crack (1135); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

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 nurse reported that during an intraocular lens (iol) implant procedure, a cartridge cracked as the lens was inserted and resulted in a fractured tip.There was no impact on the lens.There was patient contact but no patient impact.The surgery was completed the same day.

Event Description

Additional information was provided that the surgeon only uses certain lens models.These lens models are only qualified for use with other company cartridges.It is unknown if a qualified handpiece was used.

Manufacturer Narrative

Six company cartridge cartons were returned for the reported company cartridge lot# 15096777 related to three complaint files.The used complaint company cartridge was not returned.Initially, two opened and four unopened company cartridge cartons were returned for the company cartridge lot # 15096777.There were a total of seventy-nine samples returned.Eight samples were randomly pulled from the seventy-nine unopened company cartridge samples returned for lot# 15096777.The eight company cartridges were microscopically examined and no damage or abnormalities were observed.The company cartridges were functionally tested per the dfu.No lens or cartridge damage was observed after the lens delivery.The cartridge was cleaned for further evaluation.Top coat due stain testing was conducted with acceptable results.The company cartridge product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that the surgeon only uses certain lens models.These lens models are only qualified for use with other company cartridges.It is unknown if a qualified handpiece was used.The root cause for the reported may be related to a failure to follow the dfu.New information was provided that the surgeon only uses certain lens models.These models are only qualified for use with other company cartridges.The use of non-qualified combinations may lead to delivery issues and/or damage to the lens or the cartridge.The used complaint company cartridges were not returned for evaluation.Eight unopened samples for the reported lot number were evaluated.No damage or abnormalities were observed.The eight samples were functionally evaluated per the dfu.No lens or cartridge damage was observed.Top coat due stain testing was conducted with acceptable results.It is unknown if a qualified handpiece was used.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Six company cartridge cartons which contained a total of seventy-nine unopened samples were returned for the reported company cartridge lot# 15096777.The used complaint company cartridge was not returned.Two opened and four unopened company cartridge cartons were returned for the company cartridge lot # 15096777.There were a total of seventy-nine unopened samples returned.Eight samples were randomly pulled from the seventy-nine unopened company cartridge samples returned for lot# 15096777.The eight company cartridges were microscopically examined and no damage or abnormalities were observed.The company cartridges were functionally tested per the dfu.No lens or cartridge damage was observed after the lens delivery.The cartridge was cleaned for further evaluation.Top coat due stain testing was conducted with acceptable results.The company cartridge product history records were reviewed and the documentation indicated the product met release criteria.It is unknown if a qualified lens model/diopter and handpiece were used.The root cause for the reported damage cannot be determined.The used complaint company cartridge was not returned for evaluation.Eight unopened samples for the reported lot number were evaluated.No damage or abnormalities were observed.The eight samples were functionally evaluated per the dfu.No lens or cartridge damage was observed.Top coat due stain testing was conducted with acceptable results.It is unknown if a qualified lens model/diopter and handpiece were used.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: 11071930
• MDR Text Key: 224280336
• Report Number: 1119421-2020-02014
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2021

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: 15096777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 01/31/2021; 02/08/2021
• Supplement Dates FDA Received: 02/01/2021; 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH II LOADING; UNSPECIFIED PROVISC
• Patient Age: 66 YR