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 Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2020

Event Type  malfunction  

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 facility representative reported that during an intraocular lens (iol) implantation procedure, when loading the lens the cartridge cracked.In the surgeon's opinion the cause of the event was "cartridge broke".There was patient contact.The procedure was completed with another lens.There was no patient harm.Additional information was requested and received.

Manufacturer Narrative

Additional information provided in d.10., h.3.And h.10.Evaluation summary: the cartridge complaint sample was not returned.The lens was returned in the lens case.Viscoelastic is observed on the lens.One haptic is folded in on the anterior optic surface, typical of being loaded into a cartridge.No lens damage was observed.The cartridge 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 products are qualified for use with this cartridge.The root cause for the reported loading issue could not be determined.The cartridge complaint sample was not returned for evaluation, only the undamaged iol was returned.Not enough information was provided from the account for further investigation.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: 10014079
• MDR Text Key: 189877339
• Report Number: 1119421-2020-00739
• 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: other
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• 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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYST.; SN60WF.215, ACRYSOF.; UNSPECIFIED DUOVISC VISCOELASTIC.
• Patient Age: 74 YR