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

Model Number III

Device Problems Crack (1135); Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/19/2017

Event Type  malfunction  

Event Description

Additional information was received in a completed questionnaire. The haptics were placed over the lens and when they released, a crack was seen centrally on the iol. It was noted that the "kissing" haptics were not on top of each other but were next to each other. It was clarified that in the surgeon's opinion, it is unknown if the device caused or contributed to the event. This is one of two medical device reports for this event.

Manufacturer Narrative

Evaluation summary: one handpiece injector was returned for evaluation for the report of a cracked iol. A visual inspection of the iol handpiece injector was performed and was deemed nonconforming. The plunger has an upward position. A functional thread to barrel engagement check was performed and deemed conforming. A dimensional plunger position height check was performed and deemed nonconforming. The plunger position was high. The handpiece injector was manufactured in may 2013. The evaluation does confirm the injector plunger has a high plunger position which may have contributed to the cracked lens. The root cause for the nonconforming plunger height condition is usually from its use or handling, but when and how the plunger position became high cannot be determined from this evaluation. Based on the injector being manufactured over four years ago, the complaint issue does not point to a manufacturing issue. (b)(4).

Manufacturer Narrative

Additional information provided. The device was received by a company representative and is in transit to the manufacturing site for investigation. Investigation including root cause analysis will be completed. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. 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. The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The product was not 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 doctor of ophthalmology reported that during a cataract removal with intraocular lens (iol) implant procedure, the injector cracked the lens next to the center and the lens haptics were stuck on top of the lens. It was noted that there had been no problems pushing the lens out. The procedure was completed following a 30 minute delay; the cracked lens was taken out and replaced with a new one. Clarification was received that the nurse's folding of the lens is the suspected cause of the event. Additional information has been requested.

• 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: 7168998
• MDR Text Key: 241266217
• Report Number: 2523835-2018-00009
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: III
• Device Catalogue Number: 8065977773
• Device Lot Number: 929258M
• Other Device ID Number: 00380659777738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 01/05/2018 Patient Sequence Number: 1