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

Model Number III

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A sample product was not returned for analysis.There has been no change in criticality for this complaint.A review of the device history records traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there were no additional complaints associated with the lot for the reported issue.A root cause has not been identified.Additional information was requested.(b)(4).

Event Description

A clinic professor reported that upon receipt of a reusable device handpiece injector, it has been impossible to use.The screw is very hard and the plunger is uneven.It scratches lenses.In comparison to older handpieces purchased in the past, it seems very different.There was no reported patient impact.Additional information was requested.

Manufacturer Narrative

One opened handpiece injector was received for the report of "hard to screw, uneven plunger, and scratches on the lens." a visual inspection of the iol handpiece injector was performed and was deemed conforming.A functional thread to barrel engagement check was performed and deemed conforming.Finally, a dimensional plunger position height check was performed and deemed conforming.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The injector was manufactured in july 2018.The two photos provided with the complaint file were reviewed.Photo one shows a an injector.Photo two shows the box label with the product item and lot number documented in this complaint file.The evaluation does not confirm the injector was the root cause for the lens scratches, the injector handpiece met specification.The reason for the complaint issue cannot be determined from this evaluation.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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
• MDR Report Key: 8387985
• MDR Text Key: 138073977
• Report Number: 2523835-2019-00077
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2019

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: III
• Device Catalogue Number: 8065977773
• Device Lot Number: 250956M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/04/2019
• Supplement Dates Manufacturer Received: 03/07/2019; 12/23/2019
• Supplement Dates FDA Received: 03/08/2019; 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1