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 Scratched Material (3020)

Patient Problem No Information (3190)

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 lens was scratched.The lens remains implanted.Additional information has been requested.

Manufacturer Narrative

The associated iols were not returned.The lenses remain implanted.The customer returned two ¿test¿ lenses as an example of the damage that is being observed.These two returned lenses were evaluated.Damage is observed on the edge of the lenses with an inward path.One lens has large cracks.The second lens has the same cracks and a scrape.The damage has the appearance of damage that can occur from a misaligned or damaged handpiece plunger.Two cartridges were returned with each lens.One returned cartridge had no sign of use.The three returned used company iii (d) cartridges are all damaged.All three had inadequate viscoelastic observed.Two have very large aneurysms on the right side.One is cracked in the nozzle, which extends into a split as it enters the thinner tip material.It cannot be determined if these company iii (d) cartridges were actual complaint samples or used with the ¿test¿ lenses.Fifty-eight unopened samples were returned for company iii (d) cartridge lot 32705416.Six unopened samples were pulled randomly, one from each returned carton.All six unused company iii (d) cartridges were visually examined and found acceptable.The six cartridges were functionally tested.No lens damage occurred.Top coat dyes stain testing was conducted with acceptable results for the presence of top coat.Company product history records were reviewed and documentation indicated the product met release criteria.The specific lens model/diopter information was not provided.The customer indicated (sn and sa) and non-alcon lenses were used.It cannot be determined if the lenses used were qualified.The handpiece and viscoelastic indicated are qualified with company iii (d) cartridge for the company iols only for the diopter range of 6.0-27.0.The root cause for the reported ¿scratched¿ lenses could not be determined.The lenses remain implanted and no photos were provided of the damage.Based on review of the returned customer ¿test¿ lenses the damage may be related to a loading issue or a damaged handpiece plunger.The lenses are cracked on the edge.The cracks observed radiate from the edge inward.A scrape is also observed on one sample.This damage also has an inward travel path.This damage is similar in appearance to damage that can occur from a handpiece plunger.The damage observed with the returned used cartridges is also indicative of a lens/plunger being out of position as the lens is advanced.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.Functional testing was conducted with six of the returned unopened samples from the complaint lot.The six cartridges were functionally tested with company, 27.0 diopter lenses, a company iii handpiece and a qualified viscoelastic.No problems were observed during loading or delivery.No lens damage was observed after delivery.Complaints were provided to the director of surgical sales training for follow-up.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: 9193524
• MDR Text Key: 172716094
• Report Number: 1119421-2019-01700
• 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: 12/17/2019

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 8065977763
• Device Lot Number: 32705416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED IOL