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); Scratched Material (3020)

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

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A physician reported that during a cataract surgery with an intraocular lens (iol) implant, the optic was scratched due to a damaged cartridge.The iol was removed from the eye the following day.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the cartridge and iol were not returned.Only the empty lens case was returned inside the carton.Two photos are attached for two files.Two photos of implanted lenses were provided.Toric axis marks can only be observed in one of the photos.Both photos have what appears to be a large scrape mark or foreign material near the center of the lens.A determination of damage cannot be made without evaluation of the sample.It cannot be determined from the photo if the possible damage is on the anterior or the posterior surface.It is unknown if a qualified handpiece and viscoelastic were used.The product investigation could not identify a root cause for the reported complaint.Results of the photo review are inconclusive.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: 10118658
• MDR Text Key: 194034135
• Report Number: 1119421-2020-00817
• 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
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• 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
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TFNT20 24.0 D; TFNT20 24.0 D
• Patient Outcome(s): Required Intervention