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

Model Number	SN6CWS
Medical Device Problem Codes	Inaccurate Delivery (2339); Defective Device (2588); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Capsular Bag Tear (2639); Eye Pain (4467)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that, during intraocular lens implantation surgery, the injector jammed preventing the lens from advancing into the eye.After a forceful injection, the lens shoots out as a bullet causing the posterior capsule to rupture.Postoperatively, there was a lens deviation, decreased vision and eye pain.The repositioning of the lens was done to correct the lens position.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available the manufacturer internal reference number is: 2023-82135.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The product investigation could not identify a root cause for the reported complaint.The device was not returned for an evaluation.The lens remained in the eye.Information was provided in the initial report description that indicated usage: "the pre installed crystal injector is used abnormally, causing the injector to jam and preventing the artificial lens from being inserted into the eye.After forceful injection, the artificial lens shoots out like a bullet, causing the posterior capsule to rupture".It is unclear what was meant by the injector was "used abnormally".It cannot be determined based on the information provided if the steps of the ifu were followed.It is unknown if a qualified viscoelastic was used in the device.Material properties of a non-qualified viscoelastic may contribute to underfill, overfill, misfolding of the trailing haptic, lack of lubricity or other unpredictable outcomes.It is unknown if a sufficient amount of viscoelastic was used.The ifu instructs: fill the device until viscoelastic can be observed flowing to the line on the nozzle tip.This will require approximately 0.2 ml of viscoelastic.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device.Per the ifu: when the lens stop has been removed, gently advance the plunger in one smooth continuous motion until the front edge of the optic aligns with the nozzle "fill to" line.The plunger advancement should require at least 7 seconds.It is important not to advance the plunger abruptly as improper folding and lens damage may occur.After the plunger has been advanced to align the front leading edge of the optic with the "fill to" line, the lens should be visually inspected to determine the position of the haptics.(pictures of acceptable haptic positions are included in the ifu).The plunger should be in contact with the trailing optic edge.No part of the lens should exit the nozzle prior to insertion through the incision.After confirming the lens is properly positioned, and the haptics are folded properly, proceed with lens implantation by inserting the nozzle tip through the incision and positioning the nozzle tip at the anterior capsule opening.Gently advance the plunger in one, smooth, continuous motion.Do not advance the plunger too fast, or lens damage may occur.The recommended time to deliver from inspection of the haptics is 5 seconds.As the lens begins to exit the nozzle tip, place the leading haptic into the capsular bag and continue to slowly advance the plunger to deliver the lens.As the optic portion exits the nozzle tip.Rotate the device as needed to ensure the lens unfolds anterior side up within the capsular bag.And in a planar fashion parallel to the iris.After the plunger has been fully advanced, pause for a moment before retracting the device to allow the lens to release from the plunger tip.Follow up attempts were made for additional information.No further information has been provided.If additional information becomes available, the file will be reopened and updated.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
• Common Device Name: 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: 18335480
• Report Number: 1119421-2023-02162
• Device Sequence Number: 6712478
• Product Code: KYB
• UDI-Device Identifier: 00380652249171
• UDI-Public: 00380652249171
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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
• Operator of Device: Health Professional
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.180
• Device Lot Number: 15502432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown