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	06/02/2025
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 nurse reported with a description; there was a loading failure and one haptic leg seems to be broken.There was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in b.3.,b.5.,d.9.,d.10.,h.3.,h.6 and h.11.The device with the lens was returned.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced to mid loading area and a plunger underride was observed.The lens was in the loading area, rotated and positioned on the plunger tip.One haptic was bent in the gusset and distal area.There was no broken haptic damage observed.The lens door was opened upon returned.The lens door closed and locked securely.No damage was observed to the lock or hinge.The lens was cleaned with klotho-related protein (klrp) to further evaluate.The haptic returned to the original position after the removal of the dried viscoelastic.No other lens damage was observed.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.A plunger underride was observed in the loading area.The lens was rotated on the plunger tip and the haptic was bent.It is unknown if the bent position of this haptic may have been interpreted as the report of one haptic leg seems broken.There was no broken haptic damage observed.The root cause for the reported event may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used.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.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 the device is overfilled with ovd, this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.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.Information was provided that the product was loaded with a lot of non-company ovd, and during loading the lens bone was broken or when opening the lens, lens door opened and pulled the lens.Unable to reload.The customer does not wish to be contacted.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received, the lens was loaded with non-company viscoelastic and when loading the lens, haptic was broken.There was no patient contact.

• 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: 22412077
• Report Number: 1119421-2025-01852
• Device Sequence Number: 12850264
• Product Code: HQL
• UDI-Device Identifier: 00380652394758
• UDI-Public: (01)00380652394758(17)271022(11)241023(10)15943805
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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: 15943805
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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: NUVISC.
• Patient Sex: Unknown