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 Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, there was a film on the posterior side of the iol after implantation with a cartridge.Additional information was requested.

Manufacturer Narrative

Additional information provided in h.3., and h.10.The company iii (d) cartridge was not returned for evaluation.Photos were provided of the lens in the eye.A strip of material can be observed slightly off center.It cannot be determined from the photos if this is on the anterior or posterior surface.The nature of the material cannot be determined from the photo.Monarch product history records were reviewed and documentation indicated the product met release criteria.The indicated lens model/diopter is qualified for use.It is unknown if a qualified handpiece and viscoelastic were used.The product investigation could not identify a root cause for the reported complaint.The company iii (d) cartridge was not returned for evaluation.Based on review of the provided photos there appears to be a foreign material on the lens.No determination can be made without physical evaluation of the complaint sample.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: 10627273
• MDR Text Key: 210606619
• Report Number: 1119421-2020-01377
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

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: 15012057
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/05/2020
• Supplement Dates Manufacturer Received: 11/14/2020
• Supplement Dates FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SA60WF.180, SP AS ASPHERIC UV ABSORBING, HWV