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 Break (1069)

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

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported that during an unspecified number of intraocular lens (iol) implantation procedures, nine cartridges burst.The procedures were completed without patient harm.Additional information has been requested; however, further information has been requested.

Manufacturer Narrative

Only the opened reported complaint cartridge pouch was returned for the reported lot number.The reported complaint cartridge sample was not returned.A different cartridge model was returned which has been subjected to abnormal pressure.The cartridge is crushed/broken at the loading area through the wing section.Extreme pressure would be needed to cause this damage (this matches the photo provided by the logistics group of the sample upon their receipt).It appears the sample was damaged in transit to the logistics center as there is also damage to the returned cartridge pouch.It is unclear why the unreported cartridge sample was returned.Attempts to clarify indicated no issue had been reported with the returned cartridge sample.The sites used both models.It appears the wrong sample was returned.The product history records were reviewed and documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.It was indicated the lens were 25.5 or less diopters.All models are not qualified for use for the same diopter ranges.Some models are only qualified up to 23.0 and 25.0.Without the specific lens models it cannot be determined if the lenses used were qualified.The root cause for the reported issue could not be determined.The reported complaint cartridge samples were not returned.The site indicated they have no had any further issues.It was indicated the lenses used were 25.5 or less diopters.All models are not qualified for use with the complaint cartridge for the same diopter ranges.Some models are only qualified up to 23.0 and 25.0 diopter.Without the specific lens models it cannot be determined if the lenses used were qualified.There are no other complaints in this lot.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: 11375825
• MDR Text Key: 234624764
• Report Number: 1119421-2021-00416
• 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
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• 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: 15064658
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH IOL CARTRIDGE C; MONARCH IOL DELIVERY SYSTEM; PROVISC; UNSPECIFIED IOL TWEEZERS