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 No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that during an intraocular lens (iol) implant surgery, the tip exploded / burst when implanting the lens.The surgery was successful and there was no patient impact.

Manufacturer Narrative

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

Event Description

Additional information received stating the cartridge touched the patient but with no patient impact.This has happened two (2) - three (3) times.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.The used company iii (d) cartridge was returned.The nozzle is cracked on the right side with stress marks.The tip is split on the right side.The cartridge has evidence it was placed into a handpiece.Company complaint history and product history records were reviewed and documentation indicated the product met release criteria.A qualified handpiece was indicated.The company lens model is only qualified for use in the company ii (b) and iii (c) cartridges.The viscoelastic is not qualified for use with the lens/cartridge combination used.The root cause for the reported damage appears to be related to a failure to follow the dfu.The customer indicated the use of a non-qualified lens/monarch combination.The company lens model is only qualified for use in the company ii (b) and iii (c) cartridges.The use of non-qualified combinations may lead to delivery issues and/or damage to the lens or the company cartridge.The damage to 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.Damage in the thick cone wall section has been associated with the use of cold viscoelastic.The dfu instructs to use a qualified viscoelastic, which has been allowed to come to the operating room temperature.This type of damage may also occur 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.There did not appear to be adequate viscoelastic in the cartridge.The dfu instructs to fill the cartridge with viscoelastic before loading 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.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: 10091503
• MDR Text Key: 193302212
• Report Number: 1119421-2020-00794
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2020

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: 32733069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 06/03/2020; 06/25/2020
• Supplement Dates FDA Received: 06/04/2020; 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEALON J & J.; MONARCH III INJECTOR.; SA60AT IOL.; SA60AT.