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 Rupture (1546); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2020

Event Type  Injury  

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 cartridge burst and the haptic was torn off.The lens was removed and replaced the next day in a secondary surgery.There was no more patient impact.

Event Description

Aadditional information has been received stating the patient was male and the event occurred in the left eye.

Manufacturer Narrative

Additional information provided in a.2., a.3., b.5., and d.11.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was not returned.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 indicated associated iol is not qualified for use with the company iii d cartridge.The company lens model is only qualified for use in the company ii b and iii c cartridges.A company iii handpiece was also indicated.A viscoelastic was indicated that was not qualified for use with any company cartridge.The root cause for the reported event was most likely related a failure to follow the dfu.The account used a lens/company cartridge combination which was not qualified for use.The use of non-qualified combinations may result in delivery issues and/or damage.The company lens model is only qualified for use in the company ii b and iii c cartridges.The account also used a non-qualified viscoelastic.The viscoelastic indicated has not been qualified for use with any lens/company cartridge combinations.Due to differing material properties, the use of a non-qualified viscoelastic may result in delivery issues and/or damage.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: 10924154
• MDR Text Key: 218910339
• Report Number: 1119421-2020-01802
• 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: 02/09/2021

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 Catalogue Number: 8065977763
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 11/30/2020
• Supplement Dates Manufacturer Received: 12/09/2020; 02/09/2021
• Supplement Dates FDA Received: 12/15/2020; 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III HANDPIECE; SA60AT IOL; W2O CROWN VISCOAT; SA60AT IOL; W2O CROWN VISCOAT
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR