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 Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

A health care professional reported that during an intraocular lens (iol) implant procedure, cartridge scratched the lens surface about 2mm.The same problem did not occur when the cartridge was replaced with another lot cartridge, the surgery was completed and there was no patient harm also when inserting the lens into the cartridge, he/ she felt more resistance than usual.So he/she suspect a defect in the product.Additional information was received, the lenses were not replaced and the operation was completed without any problems.The visual acuity seems to be good now.When surgeon used a cartridge from another lot, the lens insertion was noticeably smoother unlike the product that had the problem.

Manufacturer Narrative

The used company cartridge was not returned for evaluation.Seven unopened company cartridges were returned in an opened 10-coubt carton.This lot is associated with three complaints.One of the returned unopened company cartridges was pulled randomly for evaluation.Unopened company cartridge: the company cartridge was opened and microscopically examined with no damage or abnormalities observed.The cartridge was functionally tested per the direction for use (dfu) using a qualified company handpiece, intra ocular lens(iol) model, 27.0 diopter lens and company ovd (ophthalmic viscosurgical device).The cartridge was filled with viscoelastic per the instruction for use (ifu).The lens was loaded and biased down.The lens was advanced making sure the plunger was in the correct position in contact with the trailing optic edge.No resistance was felt.No lens or cartridge damage was observed after the lens delivery.The company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The lens model/diopter was not provided it is unknown if a qualified company lens was used.A qualified handpiece was indicated.The root cause of the reported lens edge damage and resistance may be related to a failure to follow the ifu.The used company cartridge was not returned for evaluation.One of the returned unopened company cartridges was evaluated.Functional testing was conduct with no resistance felt.No lens or cartridge damage was observed after the lens delivery.Top coat dye stain testing was conducted with acceptable results.A non-qualified viscoelastic was indicated.The lens model/diopter was not provided it is unknown if a qualified company 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: 19189985
• MDR Text Key: 341116088
• Report Number: 1119421-2024-00802
• 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
• Report Date: 04/26/2024

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: 15734662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYSTEM, INJECTOR; OVD: HYAGUARD BY ROHTO