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 Malposition of Device (2616)

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

Event Date 02/03/2021

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

A health professional reported that during an intraocular lens (iol) implant surgery, a fragment/strip from the interior of cartridge depositing on posterior iol optic went into the patients eye.The plastic was removed during the initial procedure.There was no patient impact.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The company iii (d) cartridge was not returned.An opened/empty company pouch was returned for lot #15116956.The non-company lens case and pouch were also returned.A specimen cup was returned with liquid inside.The container was not opened.No obvious foreign material was observed through the container.The sample was sent to the ftw particle lab for evaluation.The solution in the specimen cup was poured into a pre cleaned petri dish.The solution, specimen cup an lid were visually and microscopically examined.Microscopic examination showed a clear particle approximately 625 ¿m in length in the interior of the lid.No other foreign material was observed.The clear particle was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the clear particle¿s generated spectra to a library of spectra found no sufficient matches.The clear particle was then isolated and analyzed using the hitachi scanning electron microscope (sem) equipped with an edax energy dispersive x-ray spectrometer (eds).Eds analysis identified carbon (c), sodium (na) and chlorine (cl).The presence of the elements along with the visual characteristics suggest the clear particle is crystallized salt.Product history records were reviewed and documentation indicated the product met release criteria.A non-alcon iol was indicated with an company handpiece.The root cause for the reported event may be related to a failure to follow the dfu.It was indicated the iol used was not a company product.Per the dfu: the company iii iol delivery system is for implantation of company qualified foldable iols.No unqualified lenses should be used with the company iii iol delivery system.The use of non-qualified product combinations may result in delivery issues or product damage.The company iii (d) cartridge was not returned for evaluation of damage.Lab testing of the returned specimen cup an its contents did not identify any material related to the monarch cartridge.The only observed foreign material was analyzed with using microscopic fourier transform infrared spectroscopy (micro ft-ir) and a hitachi scanning electron microscope (sem) equipped with an edax energy dispersive x-ray spectrometer (eds).Eds analysis identified carbon (c), sodium (na) and chlorine (cl).The presence of the elements along with the visual characteristics suggest the clear particle is crystallized salt.Per the company handpiece dfu: the qualified cartridge/iol combinations have been validated at an ambient temperature of 18 °c using the driving console setting (1.7 mm/sec, 3 seconds, and 3.0 mm/sec for initial velocity, pause and final velocity respectively).Using a higher velocity and shorter pause at lower temperatures, especially with high diopter lenses, could induce damage to iol and/or iol cartridge, affecting successful iol implantation.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: 11304570
• MDR Text Key: 232345689
• Report Number: 1119421-2021-00275
• 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,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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: 15116956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTREPID AUTOSERT HP; UNSPECIFIED DUOVISC; UNSPECIFIED PROVISC