MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	ACU0T0
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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 health care professional reported that during the intraocular lens (iol) implant procedure, it became difficult to inject the lens within the preload delivery device.The surgeon had to apply more pressure, resulting in the lens to overshot the capsule and enter partially behind the eye capsule.Which caused rupture of the capsule bag into the vitreous cavity.The lens was removed and surgeon performed a vitrectomy and sutured the cornea.The surgery was completed without the lens.The patient had poor vision because of aphakia post-procedure.Referred to other surgical team.The patient is currently on the waiting list to have secondary iol implant with them.
Additional Manufacturer Narrative
Additional information was provided in b.5., d.9., h.3., h.6.And h.11.The lens was returned adhered to an extra label set sticker, loose in the carton.Solution and adhesive were dried on the lens.The optic was cut in half, typical of insertion and removal.The device was returned loose inside the carton.The plunger lock and lens stop have been removed from the device.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was fully advanced, with the plunger tip outside the device tip.No device or plunger tip damage was observed.The nozzle was removed and cleaned for further evaluation.Topcoat dye stain testing was conducted with acceptable results.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.Viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause.It is unknown if a qualified viscoelastic was used.The instructions for use (ifu) instructs: during device preparation and implantation of the company intraocular lens (iol) with the company preloaded delivery system, a 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.The ifu instructs: take at least 7 seconds to gently fold the iol by advancing the plunger forward in one smooth, continuous motion until the front edge of the optic is even with the "fill-to" line on the nozzle.Do not allow any portion of the lens to exit the nozzle tip.At this position the blue spring will contact the clear main body.It is important to not advance the plunger abruptly to fold the iol as improper folding and lens damage may occur.After the lens has been advanced to the "fill-to" 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.No part of the lens should exit the nozzle prior to insertion through the incision.Once the lens is in position at the "fill-to" line, it should be implanted within 3 minutes.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.Topcoat dye stain testing was conducted with acceptable results.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that during the intraocular lens (iol) implant procedure, it became difficult to inject the lens within the preload delivery device.The surgeon had to apply more pressure, resulting in the lens to overshot the capsule and enter partially behind the eye capsule.Which caused rupture of the capsule bag into the vitreous cavity.The lens was removed and surgeon performed an anterior vitrectomy and sutured the cornea.The surgery was completed without the lens.The patient had poor vision because of aphakia post-procedure.Referred to other surgical team.The patient is currently on the waiting list to have secondary iol implant with them.

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22393978
• Report Number: 1119421-2025-01814
• Device Sequence Number: 13029060
• Product Code: KYB
• UDI-Device Identifier: 00380652395311
• UDI-Public: (01)00380652395311(17)270715(11)240716(10)15886847
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: ACU0T0
• Device Lot Number: 15886847
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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 Age: 86 YR
• Patient Sex: Female