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 Device Contaminated During Manufacture or Shipping (2969)

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

Event Type  malfunction  

Manufacturer Narrative

Sample products were not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that multiple cartridges from the same lot are leaving a debris on the optic of implanted intraocular lenses (iol).Another lot of cartridges are not leaving debris.There was no reported harm to patients.Additional information was requested.

Manufacturer Narrative

The complaint cartridges were not returned.Two cartridges were returned from the complaint lot.One cartridge was returned loose ( no sign of use) and one cartridge was in an unopened pouch.Both cartridges were visually examined and no damage or abnormalities were observed.Both cartridges were functionally tested per the dfu using a qualified handpiece, lens and ovd.The cartridges were filled with viscoelastic per the dfu.The lens was loaded and biased down.The lens was advanced making sure the plunger was in the correct position in contact with the trailing optic edge.No lens or cartridge damage was observed after the lens delivery.No foreign material was observed.After the functional test, both cartridges were cleaned and dye stain tested with acceptable results.No missing coating material was observed.Associated products were not provided.It is unknown if qualified product were used.The root cause for the reported event of "debris on the optic" could not be determined.The complaint cartridges used were not returned for evaluation.The "debris" was not returned for identification testing.It is unknown if qualified product were used.The two returned cartridges were visually and functionally evaluated.No abnormalities or damage was observed.No foreign material, residue or damage was observed on the lenses used for the functional testing.After lens delivery, top coat dye stain testing was conducted with acceptable results.No missing material was observed.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: 8941514
• MDR Text Key: 155957571
• Report Number: 1119421-2019-01378
• 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: 10/02/2019

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: 12/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32685205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1