MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977762

Device Problems Scratched Material (3020); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2019

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

Event Description

A physician reported during an intraocular lens (iol) implant procedure, upon advancing of lens he felt that it was not smooth as compared with his usual experience.He stated that it seemed like the lumen inside the cartridge is unusually rough and resistive even though he applied generous amount of viscoelastic onto it.The iol became stuck in the end portion of the cartridge.A second iol and cartridge were used and an iol was successfully implanted.No harm to the patient.Additional information was provide that the event happened before implantation outside of the patient's eye, so the damaged iol did not come in contact with the patient's eye.

Manufacturer Narrative

Additional information was provided.Evaluation summary: the used cartridge was returned with the qualified diopter lens model stuck between the nozzle entry area and the tip.A small amount of viscoelastic is observed.An unidentified foreign material is observed dried in a round patterns throughout the cartridge.The cartridge has evidence it was placed into a handpiece.The tip has light stress.The lens is torn/split into pieces.The cartridge was cleaned and the lens removed to facilitate testing.The unidentified foreign material could not be removed with cleaning.Top coat dye stain testing was conducted.There is evidence of top coat.The unknown foreign material could not be completely removed from the cartridge; therefore the top coat dye stain results are inconclusive.The lens was returned stuck in the cartridge.The root cause may be related to a failure to follow the directions for use (dfu).There did not appear to be adequate viscoelastic in the device.(b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• 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: 8912230
• MDR Text Key: 155184919
• Report Number: 1119421-2019-01330
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K112977
• 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: 11/12/2019

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 Catalogue Number: 8065977762
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SA60AT 20.0 DIOPTER; SA60AT.200, ACRYSOF SP FOLDABLE 6.0 OPTIC, HWV; UNSPECIFIED VISCOAT OVD, 000452, BEL; VISCOAT