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 Crack (1135)

Patient Problem No Information (3190)

Event Date 03/17/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: cartridge complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been two other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported during the implant of an intraocular lens (iol), the cartridge cracked.Additional information was requested.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.A used company iii (d) cartridge was returned for lot #15008305.Viscoelastic is observed in the cartridge.No damage is observed, only light stress.The cartridge has evidence of placement into a handpiece.Product history records were reviewed and documentation indicated the product met release criteria.Indicated associated product are qualified.The handpiece was not provided.It is unknown if a qualified handpiece was used.No problem was found with the returned cartridge.No damage is observed, only light stress.Stress is an expected occurrence with a lens delivery and does not denote a cartridge deficiency.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: 9930822
• MDR Text Key: 187482785
• Report Number: 1119421-2020-00639
• 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: 05/14/2020

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: 15008305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 05/10/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TFAT30 19.0; TFAT30 19.0 UVA; VISCOAT; VISCOAT
• Patient Age: 74 YR