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 09/13/2022

Event Type  malfunction  

Event Description

A physician reported that during intraocular lens (iol) implant procedure, more or less sticky deposit on the posterior surface of the implant after injection and difficulty of removing the deposit.Additional information has been requested.There are five medical device reports associated with this event.This report is two of five.

Manufacturer Narrative

One used company cartridge was returned.The used company cartridge was microscopically examined.Inadequate viscoelastic was observed in the cartridge.The used company cartridge had evidence of placement into a handpiece.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 left side of the tip.A video was provided.The lens and cartridge preparation were not shown.The lens was advanced slightly outside the eye.Very little ovd was observed in front of the lens as it was advanced.As the cartridge tip was inserted into the incision, pressure was applied which moved the eye up and out of view under the upper eyelid.The lens delivery could not be visualized due to this position.The lens was quickly advanced.The pressure on the eye was release allowing the eye to resume a normal position.As the lens unfolded, a narrow linear material was observed on the left side of the posterior surface originating near the optic/haptic junction.The material was removed with the i/a tip after several attempts/manipulations.The lens remained implanted.The lens appears to be the lens in the provided photo.Product history records were reviewed, and documentation indicated the product met release criteria.A qualified lens model/diopter and handpiece were indicated.A non-qualified viscoelastic was indicated.The root cause for the reported issue could not be determined.Based on the review of the provided video and the returned used company cartridge, the reported foreign material may have been internal coating material from the damaged company cartridge tip.The removed material was not returned for evaluation.A non-qualified viscoelastic was indicated and there did not appear to be adequate viscoelastic in the used cartridge.Per the ifu: 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 (diagram provided) 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.Company lens ifu note: during lens loading and insertion, do not allow the company toric 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 there are six other complaints reported in the lot.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: 15586842
• MDR Text Key: 301594629
• Report Number: 1119421-2022-02166
• 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: Physician
• Type of Report: Initial
• Report Date: 10/12/2022

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
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/12/2022
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; CLAREON TORIC IOL; Z-HYALIN FROM ZEISS
• Patient Sex: Female