MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	AU00T0
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported during intraocular lens (iol) implantation procedure, iol immediately released due to sudden step push of the injector, resulted in capsule to break.The distal haptic was straight.Due to capsule break, anterior vitrectomy was performed and an iol was implanted in sulcus.Additional information has been requested and received stating the patient condition was good after surgery.
Additional Manufacturer Narrative
The device and the lens were returned in the carton.The plunger lock and lens stop were removed.The lens stop was returned.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted toward mid-nozzle.The nozzle tip anterior was bent backward.The lens was returned wrapped in white gauze material.Solution was dried on the lens.One haptic was broken in the haptic/optic junction.The broken haptic was not returned.It is unknown if this broken haptic was the leading haptic or the trailing haptic during delivery.The optic has several small cracked areas near the broken haptic.The optic anterior was scraped near the other haptic area.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The root cause for the complaint may be related to a failure to follow the ifu.A non-qualified viscoelastic was used in the device.The ifu instructs: during device preparation and implantation of the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.Broken haptic damage and optic damage were observed.The plunger was retracted upon return.The plunger position in relation to the broken haptic during advancement cannot be determined.The ifu instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.Broken haptics may occur: due to the use of a non-qualified viscoelastic.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.In addition, haptic strength (modulus) decreases as the temperature increases and is more likely to break under stress.If the device is overfilled with ovd as this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.If a straight trailing haptic occurs and it was not properly detected to be out of position.If the plunger is not fully advanced, or if the plunger is allowed to retract, the trailing haptic may not release properly from the device.Any of the above listed causes alone, or in combination, may create the observed broken haptic damage.The reported straight leading haptic position cannot be confirmed because the lens was returned outside of the device.Straight leading haptics are not a product malfunction.A straight leading haptic may occur: due to the normal folding variations as indicated the ifu diagrams.If the initial plunger advancement is faster than the recommended target, the leading haptic may be forced past the internal folding feature.If there is excessive delay between the device preparation and subsequent delivery the leading haptic may start to unfold.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT 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: 16672115
• Report Number: 1119421-2023-00574
• Device Sequence Number: 5219589
• Product Code: KYB
• UDI-Device Identifier: 00380652394871
• UDI-Public: 00380652394871
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

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 Expiration Date: 09/19/2025
• Device Model Number: AU00T0
• Device Lot Number: 15495850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VISOC FROM TECMED AS OVD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown