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 Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/03/2022

Event Type  malfunction  

Event Description

A healthcare professional reported that during implantation of an intraocular lens (iol), plastic like deposits with a bluish glint stick to the implant.The deposits appeared during surgery when the implant was placed.The deposits were completely removed from the eye by polishing during the initial procedure.The deposits were multiple long transparent residues.Additional information was requested.

Manufacturer Narrative

The product was returned for analysis.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

A used company cartridge was returned in the opened company pouch for the given lot.Viscoelastic was observed inside the cartridge.The cartridge had evidence of placement into a handpiece.Parallel (top and bottom) pressure marks were observed on the outside of the nozzle as if it were grasped or held by an instrument.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results for the presence of top coat.Internal damage was observed with disruption in the coating on the bottom of the nozzle and left side of the tip.A photo was provided of a single-piece monofocal lens displayed on a video monitor.An area is indicated with a green circle.A linear material is observed.A determination as to the nature and origin of the material cannot be determined from the photo.Product history records were reviewed and documentation indicated the product met release criteria.An additional comprehensive record review was conducted by manufacturing science and technology (ms&t) technical steward.Qualified associated products were indicated.The root cause for the reported issue could not be determined.Based on the review of the returned used company cartridge, the reported foreign material may have been internal coating material from the damaged company cartridge tip.The damage in the nozzle may indicate a handpiece issue.The instructions for use (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.Follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the company iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.Requested refresher training for clareon lenses.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: 15697865
• MDR Text Key: 306691096
• Report Number: 1119421-2022-02311
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

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: 15473707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON IOL; CLAREON MONARCH IV INJECTOR; DUOVISC
• Patient Age: 74 YR
• Patient Sex: Female