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 Problems Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

Patient Problems Hyphema (1911); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records could not be reviewed because the reporter did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the cartridge split while the iol was in incision.According to the surgeon, the patient will require medical intervention in the future as a result of what happened with the cartridge during the procedure.Additional information was received from the initial reporter, who reported that the cartridge split while the iol was in the incision, requiring more pressure to insert.Then the mechanism of the inserter rapidly ceased to have resistance and the iol rapidly deployed across the anterior chamber, creating a two-clock hour iridodialysis with significant hyphema.The scheduled procedure was completed on the same day.

Manufacturer Narrative

A company cartridge was returned loose in a biohazard bag.Inadequate viscoelastic was dried in the cartridge.Stress lines and crack damage were observed in the thick nozzle cone wall along the anterior.The damage extended into the thinner tip material.The tip had heavy stress lines and the tip became split/cracked.The cartridge material within the damaged area of the tip has become stretched and folded at the tip exit.The cartridge had evidence that it was placed into a handpiece.The cartridge was cleaned for further evaluation.Top coat dye stain test was conducted with acceptable results.A qualified lens, handpiece, and viscoelastic were used with the cartridge.The root cause for the reported complaint may be related a failure to follow the instruction for use (ifu).An inadequate amount of viscoelastic was observed in the cartridge.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical device (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.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.The damage began in the thick nozzle cone wall on the anterior and travelled to the thinner tip area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced and not an immediate ¿burst¿ event, unless the lens was advanced at a very fast rate.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 cartridge lumen; if the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge.If the handpiece 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 cartridge, which could cause damage to the tip or the lens.The manufacturer internal reference number is:(b)(4).

Event Description

Additional information was received and stated, the patient was doing well.

• 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12719953
• MDR Text Key: 279032869
• Report Number: 1119421-2021-02031
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF IOL.; MONARCH III INJECTOR.; VISCOAT.; ACRYSOF IOL; MONARCH III INJECTOR; VISCOAT
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Sex: Male