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 Burst Container or Vessel (1074)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/12/2020

Event Type  Injury  

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, the cartridge was rinsed with by the nurse and then filled with provisc (room temperature).The lens was then inserted by the sales representative with company tweezers and then the cartridge with lens was inserted into the injector.The cartridge was docked at the tunnel, the lens could be pushed forward slightly at first, then had great resistance.Suddenly the lens had uncontrolled shooting into the eye.The lens was stuck in the chamber angle where only the end of the haptic was visible.After pulling the lens out of the chamber angle, the patient experienced iris bleeding and iridodialysis.The surgeon then noticed that the cartridge had burst.The surgery was completed with a backup lens without further complications.The sight and health of the patient was not impaired.

Manufacturer Narrative

Corrected information provided in h.10.The original g4 date reported was (b)(6) 2020 which is not correct per the corrected information received.The new date of first receipt is (b)(6) 2020.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.Product evaluation: the used company iii (d) cartridge was returned.Viscoelastic is observed in the cartridge.The cartridge nozzle has three radiating cracks.As nozzle damage progresses to the thinner cartridge tip it causes the tip to split through to the end.The company iii (d) cartridge was 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 are qualified.The root cause for the reported events could not be determined.Information was provided that the cartridge was rinsed before adding the viscoelastic.Rinsing the cartridge is not a step in the dfu.This may have caused the viscoelastic to be diluted.The company iii (d) cartridge had excessive damage.The comapny iii (d) cartridge damage on the top of the nozzle started in the thick wall cone area.Unusually high internal forces would be needed to create damage in this area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.This type of damage typically occurs if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the nozzle lumen; if the lens is advanced too rapidly or if the plunger is not positioned correctly at the trailing optic edge.If the plunger is not positioned at the trailing optic edge it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the nozzle, which could cause damage to the tip or the lens.Top coat dye stain testing was conducted with acceptable results.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: 9751559
• MDR Text Key: 180827909
• Report Number: 1119421-2020-00289
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32628678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 03/04/2020; 04/08/2020
• Supplement Dates FDA Received: 03/04/2020; 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SN60WF IOL.; UNSPECIFIED PROVISC.
• Patient Outcome(s): Other