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

Model Number	AU00T0
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
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 with a description of intraocular lens(iol) not unfolding correctly.Additional information has been received and stated that the surgery was completed with the replacement lens.There was patient contact and no patient harm.
Event or Problem Description
Additional information has been received and stated that the lens was partially injected but didn't unfold correctly with the haptic leading and then removed.
Additional Manufacturer Narrative
Additional information was provided in b.5., d.9., h.3., h.6.And h.11.The device and the lens were returned.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was almost completely advanced.The plunger tip was slightly beyond the nozzle tip.The trailing haptic was extended backward at the plunger groove, caught in the nozzle tip.The haptic distal tip was oriented toward the loading area.The lens was returned adhered to the exterior of the device barrel.Viscoelastic was dried on the lens.One haptic was broken in the gusset area.The broken portion of the haptic was present inside the used device nozzle tip.The optic edge was broken.The broken portion of optic material was not returned.The optic was torn from the edge to the optic center.The one full haptic was easily pliable when manipulated with tweezers.The optic was fold tested using folding tweezers.The optic folded and unfolded with no abnormalities observed.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.The plunger was not fully advanced.The trailing haptic was extended backward, caught between the plunger and the side of the nozzle tip, and broken in the nozzle tip.This may have been interpreted as the complaint of not unfolding correctly.The root cause 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 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 plunger position in relation to the broken haptic during advancement cannot be determined.The ifu instructs: 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, 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 ( more than 23 degree centigrade or 73 degree fahrenheit) 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 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 reported event file will be reopened if new information is received.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: 22104708
• Report Number: 1119421-2025-01526
• Device Sequence Number: 15488964
• Product Code: HQL
• UDI-Device Identifier: 00380652394628
• UDI-Public: (01)00380652394628(17)270124(11)240126(10)15786314
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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
• Operator of Device: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15786314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEALON PRO UP31802.
• Patient Sex: Unknown