MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)

Model Number IV

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

A non healthcare professional reported that, during intraocular lens implantation surgery, the lens was placed into the inserter and when the surgeon was advancing the lens halfway, the surgeon noticed scratch on the lens.However, the surgeon still continued to advance the lens stating that due to patient's eye medical history, removing the lens would cause more harm to the patient.Hence the lens was left implanted inside the patient's eye.The scrub technician believed that, the top portion of the notch that pushes the lens in the inserter was the one that caused the scratch.There was no patient harm as the scratch was not in the visual axis.The lens is still implanted in the patient's eye and as per the surgeon's opinion, the prognosis of the patient was good.

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).

Manufacturer Narrative

One opened company injector was returned for evaluation for the report of upon implantation, noticed scratch on the lens.A visual inspection of the injector was performed and was found to be nonconforming.The plunger was found to be bent slightly upward at the plunger head and clear and white foreign material was visible on the plunger.A functional thread to barrel engagement check was performed and was found to be conforming.Finally, a dimensional inspection for plunger position height was performed and was found nonconforming due to the bent condition of the plunger.The injector was sent for particle analysis of the clear and white foreign material.Particle analysis found the foreign material was found to best match viscoat.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The evaluation does confirm the injector plunger has a bent plunger head resulting in a upward plunger position, which could result in the plunger scratching the lens.The root cause for the nonconforming plunger height is unknown.How and when how the plunger position became damaged cannot be determined from this evaluation and a root cause cannot be determined.The most likely cause of a bent plunger head of the injector is from improper handling of the product.This injector has been in service for approximately 13 years.A secondary contributing factor to a scratched lens is that the returned sample was found nonconforming with foreign material on the plunger.Particle analysis found the foreign material to be viscoat.Viscoat is not a material that is used in the manufacturing or packing process of company handpiece.How and when the foreign material became present on the injector cannot be determined from this evaluation; therefore a root cause cannot be determined for the complaint as described by the customer.Most likely source of the viscoat is from use during surgery or that the injector was not cleaned properly.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18675168
• MDR Text Key: 335004304
• Report Number: 2523835-2024-00103
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777745
• UDI-Public: 00380659777745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212039
• 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,Followup
• Report Date: 05/15/2024

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 Model Number: IV
• Device Catalogue Number: 8065977774
• Device Lot Number: 14E0KW
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2024
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/15/2024
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: CLAREON IOL.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 43 YR
• Patient Sex: Female