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 Biofilm coating in Device (1062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

The head technician who handles the materials at the surgery center reported that three doctors have had issues with film on the posterior side of intraocular lenses (iol) after implantation.The technician thinks that this is due to these cartridges because it has also happened with a different manufacturer's iol while using this cartridge.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the cartridge was not returned for evaluation.Two lenses were indicated.Only one is qualified for use with the cartridge for an approved diopter range.The other model is a competitor's lens (not qualified).It is unknown if a qualified handpiece and viscoelastic were used.The product investigation could not identify a root cause.The cartridge was not returned for evaluation.No determination can be made without physical evaluation of the complaint sample.A company representative sited the site.The company representative provided information that the lenses are being preloaded 10 minutes before the cases start.It was also observed that the or technician used the sharp part of the forceps to advance the lens.This is the technician preference.Technician was informed using the sharp part of the forceps could incur damage.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: 10569254
• MDR Text Key: 208528902
• Report Number: 1119421-2020-01299
• 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: other
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

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: 15084709
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 11/10/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BAUSCH & LOMB IOL; UNSPECIFIED PANOPTIX TORIC