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 Difficult to Advance (2920)

Patient Problem No Code Available (3191)

Event Date 02/20/2019

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 have been no other complaints reported in the lot number.(b)(4).

Event Description

A health professional reported that during an intraocular implant (iol) procedure, the surgeon needed force to advance the lens during implantation.The lens shot out and a capsular defect was noted.The surgeon had to remove vitreous from the anterior chamber of the eye before implanting the lens.The surgery was completed and the symptoms resolved without any further treatment.Additional information ha been requested.

Manufacturer Narrative

The company iii (d) cartridge with the reported issue was not returned.Four unopened company iii (d) cartridges for lot# 32628704 were returned in the opened carton.Two of the cartridges were opened and evaluated.The two unused company iii (d) cartridges were visually inspected.No damage or abnormalities were observed.The two unused company iii (d) cartridges were functionally tested per the dfu using a qualified company iii blue handpiece, company lens, 27.0 diopter lens and viscoelastic.The cartridge was filled with viscoelastic per the dfu.The lens was loaded and biased down.The lens was advanced making sure the plunger was in the correct position in contact with the trailing optic edge.No lens or cartridge damage was observed after the lens delivery.The two company iii (d) cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.Company product history records were reviewed and documentation indicated the product met release criteria.The lens model/diopter used during the event was not provided.It is unknown if a qualified product was used.It cannot be verified if the reported handpiece and viscoelastic are qualified without the associated lens model.Root cause: the company iii (d) cartridge with the reported issue was not returned.The root cause for the reported issues cannot be determined.Two of the returned unopened samples for the company iii (d) complaint lot# 32628704 were evaluated.No problems were found.The two unused company iii (d) cartridges were visually inspected.No damage or abnormalities were observed.The two unused company iii (d) cartridges were functionally tested per the dfu using a qualified company iii blue handpiece, company lens, 27.0 diopter lens and viscoelastic.The cartridge was filled with viscoelastic per the dfu.The lens was loaded and biased down.The lens was advanced making sure the plunger was in the correct position in contact with the trailing optic edge.No lens or cartridge damage was observed after the lens delivery.The two tested company iii (d) cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The lens model/diopter used during the event was not provided.It is unknown if a qualified product was used.It cannot be verified if the reported handpiece and viscoelastic are qualified without the associated lens model.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: 8387135
• MDR Text Key: 137720100
• Report Number: 1119421-2019-00254
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32628704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/04/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASICO ROYALE HANDPIECE; PROVISC; ASICO ROYALE HANDPIECE; PROVISC
• Patient Outcome(s): Required Intervention