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	Break (1069); Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
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 sample was not returned.The root cause could not be determined for the reported complaint of trailing haptic stuck to plunger and broke during surgery.It is unknown if a qualified viscoelastic was used.The instruction for use (ifu) instructs during device preparation and implantation of the intraocular lens (iol) with the company preloaded delivery system, and 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 reported 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 following 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 or more than 23 degrees celsius 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 or 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 reported event this complaint has been reported by the regulatory authority itself.No follow up possible.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4);.
Event or Problem Description
This report was received from medsafe health authority via a non-healthcare professional stated that during an intraocular lens (iol) implantation procedure, surgeon had deployed the plunger and inserted the iol into the patient¿s right eye.The surgeon observed that the trailing haptic of the iol was firmly stuck to the tip of the plunger and was difficult to remove.It subsequently broke.The procedure was completed on the same day.No further information expected.
Additional Manufacturer Narrative
The device and lens were returned in a plastic bag inside the carton.The plunger lock and lens stop were removed.The plunger was correctly oriented and fully advanced, with the plunger tip extending beyond the nozzle tip.Viscoelastic was observed inside the device.No device damage or abnormalities were observed.The lens was returned outside the device, loose in the bag.Dried viscoelastic was observed on the lens.One haptic was broken at the gusset area and adhered to the optic.The optic was broken/torn into multiple pieces, and some pieces, including the other haptic, were missing and not returned for evaluation.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.Associated viscoelastic was not provided.It is unknown if a qualified viscoelastic was used.The root cause could not be determined for the broken haptic.The lens with a broken haptic was returned outside of the device loose in a plastic bag.The optic was broken/torn into multiple pieces, and some pieces, including the other haptic, were missing and not returned for evaluation.The plunger position in relation to the broken haptic during advancement cannot be determined.The instructions for use (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 ophthalmic viscosurgical device (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 reported event this complaint has been reported by the regulatory authority itself.No follow-up possible.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: 22686337
• Report Number: 1119421-2025-02114
• Device Sequence Number: 13011826
• Product Code: HQL
• UDI-Device Identifier: 00380652394727
• UDI-Public: (01)00380652394727(17)270403(11)240404(10)15830935
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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: 15830935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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
• Patient Sex: Unknown