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 Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.The cartridge is not available because it was discarded.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.A photo was available that showed the lens inside the eye.A heavy scrape mark that has ruffled back the optic material in the line of damage was observed near the periphery of the optic.This was most likely interpreted as the reported complaint.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that linear deposit was found adhered when the intraocular lens (iol) was inserted using the cartridge.The surgery was completed without removing the foreign material, and no abnormality was found on examination the next day.There was no patient harm.The surgeon suspected that the foreign material was cartridge coating, although the surgeon was not completely sure, as iol was not removed before.The cartridge is not available because it was discarded.The lens remains implanted in patient's eye.Additional information was requested, but no further information is available.There are three medical device reports associated with this report.This is 3 of 3.

Manufacturer Narrative

The product was not returned.A photo was provided.The photo showed part of the eye.The peripheral optic edge was visible in the photo.No foreign material was observed.A long scrape mark was observed.The damage to the optic surface was most likely interpreted as the reported complaint.A qualified handpiece and viscoelastic were indicated.The lens model/diopter was not provided.It is unknown if a qualified lens was used.Based on review of the provided photo the reported ¿deposit¿ was most likely the observed lens damage.A long scrape mark was observed.The damage to the optic surface was most likely interpreted as the reported complaint.The root cause for the lens damage could not be determined from the photo.The lens model/diopter was not provided.It is unknown if a qualified lens was used.The ifu instructs: the company iol delivery system is for implantation of qualified company foldable iols.No unqualified lenses should be used with the company iol 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).

• 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: 17756551
• MDR Text Key: 323515974
• Report Number: 1119421-2023-01616
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/27/2023

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: 15618555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE