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 Defective Device (2588); Device Contamination with Chemical or Other Material (2944)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2022

Event Type  malfunction  

Event Description

A physician reported during the intraocular lens implantation abrasion occurred in the cartridge.This abrasion has occurred several times.The abrasion adhered to the back of the iol and could only be removed with difficulty.Additional information has been requested.There are three medical device reports associated with this event.This report is for 1 of 3.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been seven other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The used complaint company cartridge was not returned.Seven 10-count cartons for lot were returned.Six were unopened (60) and one was opened with (5) samples inside.One unopened company cartridge was randomly pulled from each returned carton.The samples were numbered 1-7 for evaluation purposes.The seven returned company cartridges were opened and microscopically examined with no damage observed.No particulate was observed inside the cartridge lumens.The company cartridges were functionally tested per the instructions for use ifu.No lens or cartridge damage was observed after the lens delivery.No foreign material was observed.The company cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.A qualified viscoelastic was indicated.The lens model/diopter and handpiece were not provided.It is unknown if a qualified combination was used.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.Seven of the unopened company cartridges returned for the reported lot were evaluated.No foreign material was observed.Functional and dye stain testing was conducted with the unopened samples with acceptable results.No foreign material was observed after the functional testing.Per the ifu: the company delivery system is for implantation of qualified company foldable iols.No unqualified lenses should be used with the company delivery system.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable iols.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The ifu instructs to completely fill the cartridge with ovd 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).

Event Description

Additional information has been requested and received stating there was no injury or harm to the patient, the fibers came from the cartridge and got into the patient eye and were sucked out from the eye.There are three medical device reports associated with this event.This report is for 1 of 3.

• 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: 15656109
• MDR Text Key: 306701640
• Report Number: 1119421-2022-02256
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 15374791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2022
• Initial Date FDA Received: 10/22/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IOL, UNSPECIFIED; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE