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 Defective Device (2588); Device Damaged by Another Device (2915)

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

Event Date 09/15/2023

Event Type  malfunction  

Event Description

A facility representative reported that during intraocular lens (iol) implant procedure, lens got messed up because the plastic cartridge was defective.The procedure was completed with a back up lens and no harm came to the patient.Additional information has been requested.

Manufacturer Narrative

The company cartridge was not returned for an evaluation.The lens was returned positioned incorrectly in the lens case inside the lens carton.Viscoelasetic was dried on the lens.One haptic was bet over a post of the lens case and the gusset edge was split over the post.The other haptic was bent in the distal area due to the position in the lens case.The optic was positioned on and against two other posts of the lens case.The optic was torn and split against the two posts of the lens case.A photo was in the file of the lens with viscoelastic and positioned on posts of the lens case.No damage could be observed in the photo due to clarity.Complaint history and company product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.Viscoelastic and handpiece information was not provided.It is unknown if qualified products were used with this qualified lens/cartridge combination.The root cause cannot be determined for the reported complaint of company cartridge was defective.Not enough information was provided by the account to conduct a review of the company product history records.It is unknown if a qualified viscoelastic and handpiece were used.The instruction for use (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 associated lens was returned with solution and damage.A photo was provided in the file; however, damage could not be confirmed from the photo.Viscoelastic was observed on the lens in the photo and the lens was positioned on the posts of the lens case in the photo in such a way that lens damage would have been created when the customer placed the lid and twisted the lens case closed.The damage observed upon receipt at the manufacturing site was similar in appearance to lens case related damage.If a lens becomes misaligned in the lens case, lens damage may occur.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: 18159146
• MDR Text Key: 328392768
• Report Number: 1119421-2023-01923
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/17/2023

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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CLAREON IOL