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 Fracture (1260); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2019

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 iol product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.There has been one other similar complaint reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A certified ophthalmic technician reported that during an intraocular lens (iol) implant procedure, the tip of the cartridge split while attempting to insert the lens.The surgery was completed with this iol.Additional information was provided indicating that the operating room temperature was 68 degrees.The proper amount of viscoelastic was used in the cartridge.The viscoelastic was at room temperature.The cartridge tip was split and had stress fractures.A new cartridge was used and the same lens was implanted without problems.

Manufacturer Narrative

Evaluation summary a used cartridge was returned in the opened pouch.Inadequate viscoelastic is observed in the cartridge.Heavy stress is observed in the nozzle area behind the parting line.There is an aneurysm at the parting line, which splits through the end of the tip.The cartridge has evidence it was placed into a handpiece.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The provided associated products are qualified for use with the cartridge.The reported tip damage was observed.The root cause for the damage may be related to a failure to follow the directions for use (dfu).There did not appear to be adequate viscoelastic in the device.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: 8708909
• MDR Text Key: 148659618
• Report Number: 1119421-2019-00953
• 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
• Report Date: 08/29/2019

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: 02/29/2024
• Device Catalogue Number: 8065977763
• Device Lot Number: 32701852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 08/06/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC; MONARCH II LOADING FORCEPS; MONARCH III HANDPIECE; SA60WF 23.0 DIOPTER
• Patient Age: 78 YR