MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977758

Device Problem Break (1069)

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

Event Date 07/17/2019

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.(b)(4).

Event Description

A customer reported a crushed cartridge.Timing and patient impact are currently unknown.Additional information was requested.

Manufacturer Narrative

The product was not returned.Photos of the cartridge being held with an ungloved hand were provided.Only the tip of the cartridge is shown.The tip is bent downward or pinched, which has caused the sides to bow out slightly.A large amount of stress is also observed which would also indicate pressure was placed on the tip.The clear portion of the pouch is not shown; pressure marks cannot be determined.Monarch product history records were reviewed and the documentation indicated the product met release criteria.Associated products were provided, however it was indicated that the damage was noticed before use.The product investigation could not identify a root cause based on the provided photo.Based on our observation of the attached photos, the tip is bent/damaged.A team was assembled across company functions to investigate the manufacturing, quality control and packaging/shipping of the company b product.Units are individually pouched, sterilized, and groups of 10 units are packaged into cartons for shipment to the distribution center.While it is not impossible for a defective cartridge to leave the manufacturing facility, rigorous and validated processes have been established in order to prevent this from happening.Multiple ship test assessments have proven the adequacy of various shipping configurations during site-to-site transfer.Based on your reports, further investigation is being conducted on the existing controls during site-to-site transfer.It is difficult to make a determination of handling / damage without evaluation of the physical sample.A final root cause cannot be determined based on available information.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 9106269
• MDR Text Key: 165228222
• Report Number: 1119421-2019-01559
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K001157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 8065977758
• Device Lot Number: 32699700
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUOVISC; MONARCH HANDPIECE; UNSPECIFIED DUOVISC; UNSPECIFIED MONARCH IOL DELIVERY SYST
• Patient Age: 76 YR