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 Explosion (4006)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2019

Event Type  malfunction  

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

Event Description

A health professional reported that during an intraocular lens (iol) implant surgery, the cartridge exploded.There was no patient impact.Additional information has been requested.

Manufacturer Narrative

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

Manufacturer Narrative

The company iii (d) cartridge was returned with the lens partially inserted into the loading area for return.Viscoelastic is observed in the cartridge.The cartridge has evidence it was placed into a handpiece.The cartridge nozzle is cracked in the middle (bottom).The crack extends to the tip where it splits as it enters the thinner tip material.The cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.The associated lens model is a qualified combination.The handpiece and viscoelastic used were not provided.It is unknown if qualified products were used.The company iii (d) cartridge was damaged.The root cause for the damage could not be determined.The returned company iii (d) cartridge nozzle is cracked on the bottom (midway).This damage progresses into to the of tip where is splits as it enters the thinner tip material.This type of damage is typically progressive and worsens as the lens is advanced.The damage on the bottom of the nozzle started in the thick wall cone area.Unusually high internal forces would be needed to create damage in this area.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.This type of damage may occur if the lens is advanced too rapidly or if the handpiece plunger is not positioned correctly at the trailing optic edge.If the handpiece plunger is not positioned at the trailing optic edge, it can allow the lens to fold around the plunger tip making it too large to correctly advance through the narrow tip of the cartridge, which could cause damage to the tip or the lens.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: 9271624
• MDR Text Key: 173074535
• Report Number: 1119421-2019-01846
• 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: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 8065977763
• Device Lot Number: 32688781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 12/12/2019; 12/12/2019
• Supplement Dates FDA Received: 11/18/2019; 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SN6AT3 IOL; UNSPECIFIED INJECTOR; UNSPECIFIED IOL