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 Burst Container or Vessel (1074); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that during an intraocular lens (iol) implant surgery, the cartridge burst during implantation.The lens was able to be implanted however the lens has abrasions.There was no patient impact.This is one of several reports for this facility.Additional information has been requested.

Manufacturer Narrative

The used company iii (d) cartridge was returned.Viscoelastic is observed in the company cartridge.The cartridge has evidence it was placed into a handpiece.The tip has heavy stress and an aneurysm on the right side.The company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The monarch product history records were reviewed documentation indicated the product met release criteria.The associated iol is qualified for use with the company iii (d) cartridge.There are two non-company handpieces that have the designation provided.Only one has been qualified by the company for use with the company iii (d) cartridge.Without the specific model number it cannot be determined if the qualified model was used.The company iii (d) cartridge exhibited heavy stress and an aneurysm.This may have been interpreted as the reported complaint.The cartridge was not ¿burst¿.The root cause may be related to a failure to follow the dfu.The customer indicated the use of a viscoelastic, which is not qualified for the lens/monarch/handpiece combination used.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.There are two non-company handpieces that have the designation provided.Only one has been qualified by company for use with the company iii (d) cartridge.Without the specific model number it cannot be determined if the qualified model was used.The use of non-qualified combinations may lead to delivery issues and/or damage to the lens or the company cartridge.The observed cartridge damage typically occurs if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; or if the handpiece plunger is not positioned correctly at the trailing optic edge.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge causing damage.Top coat dye stain testing was conducted with acceptable results.There have been no changes to the manufacturing process for company iii (d) cartridges.The related iol file reported that the lenses "felt harder".The report of lens "felt harder" could be related to temperature of the operating room/or viscoelastic.The dfu instruct to use viscoelastic qualified for use that has been allowed to come to the operating room reperatrure to fill the cartridge before loading the lens.If the operating room temperature is too low (< 18°c / 64°f), lens folding and advancement may be more difficult.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: 8492104
• MDR Text Key: 141330737
• Report Number: 1119421-2019-00427
• 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: 06/14/2019

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: 04/30/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32628795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1