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 Particulates (1451)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that following an implant procedure, the device has left small particles attached to the underside of the intraocular lens (iol) (for several patients).Additional information was requested.

Manufacturer Narrative

D.3.Product manufacturing site updated as upon further review it was found that the suspect product was incorrect on the initial report as the lot number was initially provided.G.9.Manufacturer report number corrected and reported under 1119421-2021-01752 additional information was provided in h.3., h.6.And h.10.Correction information has been provided in d.1., d.2., d.3., d.4., h.4., h.8.A sample device was 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 have been one other complaints reported in the lot number.Additional information was requested but no further information is available.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The used complaint cartridges were not returned for evaluation.Fifty-one unopened cartridges were returned for the reported lot.Five samples were pulled for evaluation from the returned unopened cartridges.The five returned unopened cartridges were microscopically examined with no damage observed.No particulate was observed inside the cartridge lumens.The five cartridges were functionally tested per the dfu (directions for use).No lens or cartridge damage was observed after the lens deliveries.No foreign material was observed.The cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.The associated products were not provided.It is unknown if a qualified lens model/diopter, hand piece and viscoelastic were used.The root cause for the reported complaint could not be determined.The used cartridge complaint samples were not returned.No determination can be made without physical evaluation of the complaint samples.Five of the unopened cartridges returned for the reported lot were evaluated.No foreign material was observed.Functional and dye stain testing was conducted with the unopened samples with acceptable results.No foreign material was observed after the functional testing.It is unknown if a qualified lens model/diopter, hand piece and viscoelastic were used.Per the ifu: the company iol delivery system is for implantation of qualified company foldable iols.No unqualified lenses should be used with the company iol delivery system.The company cartridges are qualified for use with compatible company hand pieces for the surgical implantation of company qualified foldable iols.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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: 12051003
• MDR Text Key: 258957117
• Report Number: 2523835-2021-00217
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2024
• Device Catalogue Number: 8065977763
• Device Lot Number: 15133179
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1