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 Codes	Failure to Advance (2524); Device Damaged by Another Device (2915); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, plunger bypassed the iol also when advancing the iol the anterior haptic was stretched.The bulb was also tilted to the right and the lens was partially squeezed.There was no patient contact and the surgery was completed on the same day using a backup iol.Additional information was received, all the events happened in the same surgery.
Additional Manufacturer Narrative
The device with the lens was returned.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was dried in the device.The plunger has advanced the lens to mid-nozzle.The plunger was correctly contacting the trailing optic edge.The leading haptic was straight.The trailing haptic was folded onto the anterior optic surface.It is unknown if the plunger had been retracted and advanced a second time.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Topcoat dye stain testing was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.No deviations were identified and all corresponding production release specifications defined in the device master record were met.A non-qualified viscoelastic was used.The reported lens squeezed was observed as lens stuck in device.The root cause may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was indicated.The ifu instructs: during device preparation and implantation of the company intra ocular lens (iol) with 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.Lens may become stuck in 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 (greater than 23 degree centigrade / 73 degree fahrenheit) 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.Top coat dye stain testing was conducted with acceptable results.The reported plunger override was not observed was not observed upon return.It is unknown if the plunger had been retracted and advanced a second time.The reported straight leading haptic was observed.The plunger, lens and haptic positions were acceptable.The leading haptic was straight.Straight leading haptics are not a product malfunction.This is an acceptable position per the diagrams provided in the ifu.The customer indicated the use of a non-qualified viscoelastic which could be a contributing factor.A straight leading haptic may occur: due to the normal folding variations as indicated in 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.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 (greater than 23 degree centigrade / 73 degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement or contribute to incorrect haptic folding.Any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH 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: 22772391
• Report Number: 1119421-2025-02224
• Device Sequence Number: 13133426
• Product Code: KYB
• UDI-Device Identifier: 00380652394802
• UDI-Public: (01)00380652394802(17)280211(11)250212(10)15989813
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 15989813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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: BAUSCH AND LOMB EYEFILL; UNSPECIFIED REPLACEMENT LENS
• Patient Sex: Unknown