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	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during surgery, they noticed that the lens was broken.There was no patient contact.Additional information has been requested.
Additional Manufacturer Narrative
The used device with the lens was returned in the blister tray in the carton.The lens stop was removed.The plunger lock was replaced onto the device prior to return.The plunger was oriented correctly.Inadequate viscoelastic was observed in the device.The plunger was retracted to the start position in the barrel of the device.The lens was located in the loading area.The lens was slightly rotated.The leading haptic was folded onto the anterior optic surface.The trailing haptic was misfolded under the optic.The misfolded under trailing haptic suggests that a previous plunger underride had occurred.The lens was removed from the loading area and cleaned with klrp (klotho-related protein klrp) for further evaluation.The haptics relaxed and released into their original positions after the removal of the dried viscoelastic.The anterior optic surface has a scratch near the optic edge.The posterior optic surface was cracked.The cracked optic damage may have been interpreted as the reported complaint.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 information was not provided.It is unknown if a qualified viscoelastic was used.The optic was cracked.This damage was most likely interpreted as the reported complaint of "the lens was broken".The root cause may be related to a failure to follow the ifu.An inadequate amount of viscoelastic was observed in the device.The ifu instructs: fully insert the ovd cannula, perpendicular to the device, through the viscoelastic port, located in the lens stop portion of the device.Fill the device until ovd can be observed flowing to the ¿fill-to¿ line on the nozzle tip.This will require approximately 0.2 ml of ovd.Only use a company ovd qualified for use with the ultrasert¿ pre-loaded delivery system that has been allowed to come to the operating room temperature.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device.It is unknown if a qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the acrysof¿ iq iol with the ultrasert¿ 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.Due to evidence of a previous plunger underride, a retraction of the plunger, and the lens located in the loading area, this may suggest that the plunger was advanced faster than the recommended rate.Plunger underride may occur: ¿ due to rapid advancement faster than the ifu recommended rate.¿ 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 inadequate viscoelastic is placed in the device, this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to override/underride the lens.¿ if the operating room temperature is too high (> 23 degree c / 73 degree 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: 23552137
• Report Number: 1119421-2025-02930
• Device Sequence Number: 13191412
• Product Code: HQL
• UDI-Device Identifier: 00380652394789
• UDI-Public: (01)00380652394789(17)280503(11)250505(10)16029778
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 16029778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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: UNKNOWN VISCOELASTIC
• Patient Sex: Unknown