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 Crack (1135); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Event Description

A non-healthcare professional reported that during a cataract extraction with an intraocular lens (iol) implant procedure, when the injector was inserted into the cornea, the doctor noticed that the cartridge was cracked in the middle, the implantation was carried out without further problems, but the doctor noted that the implantation process was more difficult when screwing in and the plunger pushed the lens in a way different and not as smooth as in a normal transplant.Additional information was requested.There are two medical device reports associated with this patient.This report 2 of 2.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The used company cartridge was not returned for evaluation.Eight unopened company cartridges were returned for the reported lot (6 unopened 10-count cartons and 20 unopened sample in baggies).This lot was related to two files from this facility.One sample was pulled randomly from each returned carton and bag.The eight unopened company cartridge samples were opened and microscopically examined with no damage or abnormalities observed.The eight company cartridge samples were functionally tested per the instruction for use (ifu).No lens or cartridge damage was observed after the lens deliveries.The company cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The root cause for the reported complaint could not be determined.The used company cartridge complaint sample was not returned.No determination can be made without physical evaluation of the complaint sample.Eight of the unopened company cartridges returned for the reported lot were evaluated.Functional and dye stain testing was conducted with the unopened samples with acceptable results.No lens or cartridge damage was observed after the lens deliveries.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical devices (ovds) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.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.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16993047
• MDR Text Key: 316014200
• Report Number: 1119421-2023-00954
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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: 15511935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH INJECTOR.; PROVISC.; VISCOAT.