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

Model Number III

Device Problem Entrapment of Device (1212)

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

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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 facility representative reported an intraocular lens (iol) delivery system, "the haptic is getting stuck in the injector." additional information was requested.

Manufacturer Narrative

Additional information provided in d.11., g.1., and g.2.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A company iii injector sample was not received at the manufacturing site for evaluation for the report of the haptic is getting stuck in the injector; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot record reviews could not be conducted.Because an injector sample was not received at the manufacturing site and no lot information was provided, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in d.11., g1., and g.2.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: 9348941
• MDR Text Key: 182624731
• Report Number: 2523835-2019-00499
• 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: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC.; MONARCH III D CARTRIDGE.; MONARCH III D CARTRIDGE.; MONARCH III D CARTRIDGE.; SA60WF.220, SP AS ASPHERIC UV ABSORBING, HWV.; SA60WF.220.; UNSPECIFIED ALCON FORCEPS.; UNSPECIFIED ALCON FORCEPS.; UNSPECIFIED ALCON FORCEPS.; UNSPECIFIED DUOVISC.; UNSPECIFIED DUOVISC.; UNSPECIFIED LENS.
• Patient Age: 65 YR