MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number SN6CWS

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 05/09/2022

Event Type  malfunction  

Event Description

A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, crack was found on iol optic after implanted in the patient's eye, then removed.The surgery was completed after a new replacement was used.Additional information was requested.

Manufacturer Narrative

A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

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

Event Description

Additional information was requested and received.Stating, this lens was removed from the device.And placed into a cartridge to implant.

Manufacturer Narrative

The company device with the explanted lens was returned in the opened tray, inside the cardboard sleeve in the opened carton.The lens door was closed.The lens stop has been replaced into the lens door.There appears to be inadequate amount of solution in the device.The solution was only observed, on the lens in the loading area, at the nozzle entry area, where one haptic tip was extended, and a small spot in the tip.The dried viscoelastic did not resemble the typical company viscoelastic patterns.It is unknown, what specific viscoelastic was used.The plunger has been retracted to mid-loading area.And was pressed against the lens edge.The optic was cut into pieces, typical of damage created to facilitate removal from the eye.The lens pieces had been replaced into the loading area, prior to return.The portions were atop one another.One haptic extended into the nozzle entry area.The optic edge has a broken area.The broken portion was returned.Another broken area of the optic was observed, near one haptic.The optic edge near this damage was split and cracked in two areas.The damage traveled toward the optic center.A slim, linear slightly opaque colored foreign material was observed, on the posterior of the optic.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.A photo was provided to review of the lens, while inside the eye.The returned product has a linear strip of foreign material on the optic, that is similar in shape to the linear shadowed shape seen in the photo.There was no crack observed, in the photo.The linear shaped artifact was most likely interpreted as the complaint.Follow up information, indicated the lens was removed from the company device and loaded into a cartridge.This is not an approved delivery method per, the ifu.Company lens is a preloaded single use product.The cartridge information was not provided by the customer.Follow up was provided, that discovers viscoelastic was used.The root cause for the reported event was most likely, due to a failure to follow the ifu.Follow up was provided, that indicated the lens was removed from the preloaded company device and then loaded into a cartridge.This is not an approved delivery method for the company product.The company delivery system is a preloaded device manufactured for single use only.A photo of the lens inside the eye was made available.There was no crack observed, in the photo.A linear artifact that matches the artifact on the returned cut lens was observed.This was most likely interpreted as the reported complaint.The slightly opaque colored artifact was isolated and sent to particle lab for identification and analysis.The sample was visually and microscopically examined and the reported foreign material was observed.Microscopic examination shows clear material approximately 2.5 mm in length.The clear material was then isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the material¿s generated ir spectra to a library of spectra finds the best match to be monarch cartridge.The observations of the device evaluation, the explanted lens evaluation, the dye stain testing results, the photo evaluation, and the lab analysis support the customer's information, that this lens was not delivered through the company device.The lab testing, indicated best match of the material to be company cartridge material.However, "best match" is not a 100% confirmation.The customer did not indicate, the brand or model of cartridge that was incorrectly used in this event.No further information has been provided for the file.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14674209
• MDR Text Key: 293944471
• Report Number: 1119421-2022-01250
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652249287
• UDI-Public: 00380652249287
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2022

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 Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.235
• Device Lot Number: 15257422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 08/07/2022; 08/31/2022
• Supplement Dates FDA Received: 08/29/2022; 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISCOVISC; MONARCH III INJECTOR; UNSPECIFIED CARTRIDGE; UNSPECIFIED OPHTHALMIC VISCOSURGICAL DEVICE