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

Catalog Number 8065977763

Device Problems Break (1069); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that a surgeon was experiencing resistance from the handpiece as he was inserting the intraocular lens (iol).The lens and haptic broke once it was injected.The surgeon was able to remove the lens pieces during the same surgery and a new iol was inserted with no further problems.There was no harm to the patient.This is the second of two records for this facility.

Manufacturer Narrative

The company cartridge was returned.Viscoelastic was observed in the device.The tip is stressed and an aneurysm is present on the posterior.The cartridge shows evidence of being placed into a handpiece.The qualified associated intraocular lens (iol) was returned in the iol case.The iol is immersed in solution.The optic is torn/split with approx 75% of the optic returned.One haptic is bent/deformed.The other haptic was not returned.The cartridge was cleaned for further evaluation.Slight coating disruption was observed at the end of the tip.Top coat dye stain testing was conducted with acceptable results.Company product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The customer indicated the use of a qualified company handpiece and viscoelastic.The cartridge and broken lens were returned separately.The root cause of the complaint may be related to a failure to follow the dfu.The tip has stress and an aneurysm.This type of damage typically occurs if the lens is not positioned correctly for advancement; if there is a lack of viscoelastic between the lens and the cartridge lumen; or if the handpiece plunger is not positioned correctly at the trailing optic edge.This can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge causing damage.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, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7248822
• MDR Text Key: 99316167
• Report Number: 1119421-2018-00128
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2018

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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other