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 Contamination /Decontamination Problem (2895)

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

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

A product sample was returned and the 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.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported a sliver/ sticky substance on the intraocular lenses following insertion during the implantation procedure.The substance was removed during the procedure.The surgeon believes the sticky substance originated from the cartridge.The procedure was completed without patient harm.

Manufacturer Narrative

Product evaluation: two used cartridges were returned.One was in a specimen cup labeled material in tip.A particle was also returned between two glass slides.The cartridge in the specimen cup and the particle in the glass slides were sent for testing.The particle lab conducted microscopic and microscopic fourier transform infrared spectroscopy (micro ft-ir).¿ particle in the glass slides best match was cartridge base coat.¿ particle in the tip of the used cartridge best match was viscoelastic.Both used cartridges were microscopically evaluated.Both cartridges exhibited inadequate viscoelastic.Both cartridge tips had heavy stress.Both cartridges had evidence of placement into a handpiece.The cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results for the presence of top coat.A disruption was observed in the interior coating on the left side of both cartridge tips.Product history records were reviewed and documentation indicated the product met release criteria.A qualified handpiece was indicated.The lens used was not provided.It is unknown if a qualified lens model/diopter was used.The site indicated that viscoelastic was not used in the cartridges.However, a very small amount was observed in the cartridges and lab testing indicated viscoelastic.The root cause for the reported issue may be related to a failure to follow the dfu.Based on the review of the returned used cartridges and the laboratory results, the reported substance appears to have been internal coating material from the cartridge tips.The cartridges were damaged.The customer indicated that viscoelastic was not used in the cartridges.However, upon evaluation there appeared to be an inadequate amount of viscoelastic in the cartridges.The dfu instructs to fill the cartridge with viscoelastic before attempting to load the lens.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage or delivery issues.It is unknown if a qualified lens/model diopter was used.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: 11303117
• MDR Text Key: 232156162
• Report Number: 1119421-2021-00270
• 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: 03/23/2021

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: 15084723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/09/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH IOL DELIVERY SYSTEM; UNSPECIFIED IOL