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 Problems Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The 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 has been one other similar complaint reported in the lot number from the same facility.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a cataract surgery with an intraocular lens implant, a piece of very thin foreign material in a color between colorless and translucence, less than 1mm in length and 1mm in width was found on the back of an implanted iol after insertion.The physician had difficulty in aspirating it by irrigation & aspiration (i&a).The surgery was completed after performing a thorough i&a to remove it.Similar issues were seen in other surgeries on this day and the day after and the exact number is not available.The issues occurred when a different manufacturer's iol was used in each surgery.Initially, the physician suspected the iol forceps; however, a cartridge of a different lot was used in surgery which resulted in no such issues.The physician is requesting that this cartridge lot# be replaced.Additional information has been requested.There are two medical device reports associated with these unknow number of events.This report is for the events that occurred on (b)(6) 2020.

Manufacturer Narrative

Evaluation summary: the used cartridge complaint sample was not returned.The associated lens was also not returned.Ten (10) unopened cartridges in an unopened carton and seven (7) individual unopened cartridge for the same lot number as reported were returned, for a total of seventeen (17) unopened samples.Random samples were opened for evaluation.The cartridges were visually inspected with no damage or abnormalities observed.The cartridges were functional tested.No cartridge or lens damage was observed.No foreign material was observed on the iols post-delivery.The cartridges were cleaned and topcoat dye stain tested with acceptable results.A photo was provided of another manufacturer's lens in the eye.Due to the lines on the photo from the screen, it is difficult the see the lens surface.There appears to be a small particulate near the 6 o'clock position.Unable to determine if this is on the anterior or posterior surface.No determination can be made from the photo.Product history records were reviewed and the documentation indicated the product met release criteria.A non qualified, competitor's lens was indicated.This lens is not qualified for use in any of these cartridge models.An injector handpiece was indicated.The viscoelastic is unknown.The root cause for the reported foreign material could not be determined.No determination can be made without physical evaluation of the complaint sample as the complaint sample was not returned for evaluation.The root cause for the reported event may be related to the use of non-qualified associated products.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: 10525580
• MDR Text Key: 206718939
• Report Number: 1119421-2020-01252
• 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
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 32751148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 10/04/2020
• Supplement Dates FDA Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMO TECNIS LENS; INTREPID AUTOSERT IOL INJECTOR; UNSPECIFIED LENSES
• Patient Outcome(s): Required Intervention