MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH III IOL DELIVERY SYSTEM, INJECTOR; LENS, GUIDE, INTRAOCULAR

Model Number III

Device Problem Material Twisted/Bent (2981)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

A sample device was returned for analysis.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 physician reported during the intraocular lens implantation plastic material and plastic fibre have been found on the lens.The lens was removed from the eye in the same procedure.Additional information has been requested and received stating that the fibers on the posterior surface of the lens after implantation might have come from the cartridges.Additional information has been received and was clarified that the plastic material was a cellophane material and it was removed.Additional information was received stating the plunger in injector may not be straight or may be loose.Clarification was received stating that the lens was not explanted in the initial procedure rather the foreign material was removed.

Manufacturer Narrative

Correction information provided d.1., d.4., g.4.Additional information provided in h.3., h.6., and h.10.One opened company handpiece injector was returned for evaluation for the report of hard to thread.A visual inspection of the handpiece injectors was performed and both injectors were found to be conforming.A dimensional plunger position height check was performed and was found nonconforming for both handpieces.A functional thread to barrel engagement check was then performed and both samples were bound to be conforming.A photo of product and four videos are attached to the parent file and were viewed by the investigation site.The photo shows 2 company handpieces along with other items.Details of the plunger cannot be seen in the photo.The first video, per the pr numbers in the title of the attachment, is not applicable to this record.For the second video, an injector is not seen, therefore, the reported issue could not be confirmed.The third video shows the lens delivery.Details of the plunger cannot be seen in the video.The fourth video also shows lens delivery.Full details of the plunger cannot be seen in the video.A review of the device history record traceable to the possible lot numbers indicates that the possible products were processed and released according to the possible product¿s acceptance criteria.The injectors were manufactured in september 2015 & november 2007.The evaluation confirms that the plunger of both injectors had non-conforming plunger positions, which could be perceived as the injector not being straight.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.The most likely cause of a bent plunger head of the injector is from improper handling of the product.The samples have been in service for approximately 7 and 15 years.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: LENS, GUIDE, INTRAOCULAR
• 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: 14548098
• MDR Text Key: 292982469
• Report Number: 2523835-2022-00200
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380659777738
• UDI-Public: 00380659777738
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: IOL, UNSPECIFIED; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D