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

Catalog Number 8065977763

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints in the reported lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported, when implanting the intraocular lens a white fuzzy foreign material came out with it.After implanting the lens the foreign material was able to be aspirated by irrigation and aspiration and the surgery was completed without product replacement.There were no problems post operation and no patient harm occurred.

Event Description

Additional information received, the viscoelastic was filled in a sufficient amount.The site reports the vision is good after the surgery without problems.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The company iii (d) cartridge was not returned for evaluation.A video was provided.The provided video was reviewed by hwvqa, the hwv product steward and ftw r&d.The video is taken from in front of a monitor.Details are difficult to see.The lens and cartridge preparation are not shown.The cartridge tip comes into view as it is inserted into the incision.The viscoelastic looks thick as it comes out of the tip.The lens has whitish material on both sides.The observed whitish material is potentially internal coating from the cartridge.The material was removed with the i/a tip.Product history records including were reviewed and documentation indicated the product met release criteria.There are no deviations related to the reported product lot #32762531.A non-qualified company lens was indicated.This lens model is only qualified for the company ii (b) and company iii (c) cartridges.A qualified handpiece was indicated with a non-company viscoelastic.The root cause for the reported ¿white fuzzy¿ foreign material could not be determined.A whitish material was observed on the provided video.The observed whitish material is potentially internal coating from the cartridge.The used company iii (d) cartridge was not returned for evaluation.A root cause cannot be determined without physical evaluation of the product.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• 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: 11335681
• MDR Text Key: 233463189
• Report Number: 1119421-2021-00332
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 32762531
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 02/25/2021; 05/07/2021
• Supplement Dates FDA Received: 03/11/2021; 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF SINGLEPIECE IOL; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; OPELEAD