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

Model Number III

Device Problems Failure to Align (2522); Positioning Problem (3009)

Patient Problem Failure of Implant (1924)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The results from the product history record review indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.Attempts have been made to obtain additional information.(b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, the iol injector did not inject the lens correctly.Additional information was provided by a nurse that the injector was misaligned and that the lens could not be implanted during the initial procedure.The patient returned at a later date to have another lens implanted.

Manufacturer Narrative

Product evaluation: one handpiece injector was returned for the report of not injecting the lens correctly due to misalignment.A visual inspection of the handpiece injector was performed and deemed conforming.A functional thread to barrel engagement check was performed and was deemed conforming.A dimensional plunger position height check was performed and deemed nonconforming.The plunger position height is high.The handpiece was functionally tested using the returned injector with an appropriate cartridge, a 20.0d lens and a viscoelastic.The lens was delivered correctly with no damage to the lens.The evaluation confirms the injector plunger height position is higher than its specified position.Even with this nonconforming condition, a lens was able to be delivered with the returned handpiece injector without any damage to the lens.A high plunger position will increase the likelihood of a poor lens delivery.The root cause for how and when the high plunger position occurred cannot be determined from this evaluation.The most likely reason for the high plunger position is due to customer handling of the device over time.The handpiece injector has been in service over 3 years of service based on the manufacturing date of october 2013.The injector is also only design for the use of the delivery of an alcon lens.The complaint information indicates a non alcon lens was used.(b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6570143
• MDR Text Key: 75261889
• Report Number: 2523835-2017-00369
• Device Sequence Number: 1
• Product Code: KYB
• 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: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: 946738M
• Other Device ID Number: 00380659777738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH D CARTRIDGE; NON ALCON IOL; UNSPECIFIED DUOVISC
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR