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 Visual Impairment (2138); Visual Disturbances (2140)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

A materials manager reported that during a cataract extraction with an intraocular lens (iol) implant procedure, they found smudged lens and it was removed by irrigation and aspiration.Additional information was received stating one day post operation patient was seeing shadows and glare.

Manufacturer Narrative

The used company cartridge was returned.The cartridge pouch back same lot # was also returned.The used company cartridge was microscopically examined.Viscoelastic was observed in the cartridge.The tip had damage on the left side (internal).The 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 the left side.Product history records were reviewed and documentation indicated the product met release criteria.A qualified lens model/diopter and viscoelastic were indicated.The handpiece indicated is not the qualified handpiece for company.The root cause for the reported issue could not be determined.Based on the review of the returned used company cartridge, the reported "smudge" may have been internal coating material from the damaged company cartridge tip.A non-qualified handpiece was indicated.Per the instructions for use (ifu): the company intraocular lens delivery system is for implantation of qualified company foldable intraocular lenses.No unqualified lenses should be used with the company intraocular lens delivery system.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable intraocular lenses.Company foldable intraocular lenses 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 intraocular lens and potential complications during the implantation process.Follow the section regarding directions for use for information on the maximum allowed time for the intraocular lens to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in intraocular lens damage.Instructions for use (ifu) note: during lens loading and insertion, do not allow the company uv absorbing intraocular lens to remain in a folded condition within the selected intraocular lens delivery system for more than 3 minutes prior to completing insertion into the capsular bag.There has been three another complaints reported in the lot number.The manufacturer internal reference number is: 2022-61252.

• 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: 15681440
• MDR Text Key: 303174011
• Report Number: 1119421-2022-02281
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2022

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: 15384428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BSS STERILE SOLUTION; CLAREON ASPHERIC IOL; MONARCH II FORCEPS; MONARCH III IOL, INJECTOR; PROVISC
• Patient Sex: Female