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

Model Number III

Device Problems Device Damaged by Another Device (2915); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned to the manufacturing site.Root cause cannot be identified at this time.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 purchasing agent reported that during implantation of an intraocular lens (iol) the injector has a bent tip and scratched the lens.Additional information was requested.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of injector has a bent tip and scratched the lens; therefore, the condition of the product could not be verified.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.Because a sample was not received and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, the root cause for customer complaint issue cannot be determined.There have been no other complaints reported in the lot number.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: 12016148
• MDR Text Key: 256717291
• Report Number: 2523835-2021-00209
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380659777738
• UDI-Public: 00380659777738
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• 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: 277463M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED LENS; UNSPECIFIED LENS