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

Model Number	AU00T0
Medical Device Problem Codes	Failure to Fold (1255); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Hyphema (1911)
Date of Event	05/04/2026
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 non-healthcare professional reported during intraocular lens (iol) implant procedure, the trailing haptic became trapped between the plunger and the iol injector, between the blue and transparent components.It appeared that the iol had not folded correctly.Unfortunately, it was noticed once the iol was already in the eye.The lens was explanted during initial procedure.The procedure was completed on same day.Fortunately, there were no complications apart from a small iris bleed related to the explanation.The patient is in very good condition with no reported patient harm.Additional information was requested but is not available at the time of this report.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6., and h.11.The product was not returned.A batch 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 medical device file were met.A non-qualified viscoelastic was indicated.The root cause may be related to a failure to follow the ifu (instructions for use).A non-qualified viscoelastic was used in the device.The ifu instructs: during device preparation and implantation of the company specific iol (intraocular lens) with the company specific preloaded delivery system, an company specific qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd (ophthalmic viscosurgical device) may cause damage to the lens and potential complications during the device preparation and implantation steps.The account indicated the product was not available to evaluate.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.The trailing haptic may become stuck: ¿ if the plunger is not fully advanced the haptic may not release properly from the device ¿ due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.¿ 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.Any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 25360595
• Report Number: 1119421-2026-01182
• Device Sequence Number: 13444139
• Product Code: HQL
• UDI-Device Identifier: 00380652394697
• UDI-Public: (01)00380652394697(17)280324(11)250326(10)16017019
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2026

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: AU00T0
• Device Lot Number: 16017019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/02/2026
• Supplement Report FDA Received Date: 07/15/2026
• Date Device Manufactured: 03/26/2025
• 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: HPMC VISCOELASTIC SOLUTION 2%
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Male