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	Break (1069); Failure to Fold (1255); Failure to Deliver (2338); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The device with the lens was returned loose in a plastic drawstring bag.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced under the lens to almost mid-nozzle.The lens was partially advanced into the nozzle entry area.The leading haptic was misfolded underneath the optic edge.The trailing haptic was misfolded underneath the optic along the right side of the plunger.The distal area and tip were observed through the opaque device.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Neither haptic was broken.Top coat 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.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause cannot be determined for the reported complaint.A plunger underride was observed and may have been interpreted as part of the reported complaint.The trailing haptic was partially obscured in the device due to the plunger underride.There was no broken haptic damage observed.The instructions for use (ifu) instructs: during device preparation and implantation of the company intraocular lens (iol) with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.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.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 operating room temperature is too high (less than 23 degrees celsius or 73 degrees 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 customer does not wish to be contacted.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.5., d.4., d.9., d.10., h.3., h.6.And h.11.The device with the lens was returned loose in a plastic drawstring bag.The plunger lock and lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced under the lens to almost mid-nozzle.The lens was partially advanced into the nozzle entry area.The leading haptic was misfolded underneath the optic edge.The trailing haptic was misfolded underneath the optic along the right side of the plunger.The distal area and tip of the trailing haptic were observed through the opaque device.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Neither haptic was broken.Top coat 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.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.A non-qualified viscoelastic was used.A plunger underride was observed, resulting in the misfolded haptics.This was most likely interpreted as part of the reported complaint.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used.The instructions for use (ifu) instructs: during device preparation and implantation of the company 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.The trailing haptic was partially obscured in the device due to the plunger underride and may have interpreted by the customer of broken haptic damage.The lens was removed from the nozzle during cleaning.There was no broken haptic damage observed.Plunger underride may occur: due to rapid advancement faster than the instructions for use (ifu) recommended rate.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ophthalmic viscosurgical device (ovd)s may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If the operating room temperature is too high (more than 23 degrees celsius or 73 degrees 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 customer does not wish to be contacted.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated that device was filled with ophthalmic viscosurgical device so that the entire lens was covered, but when surgeon pushed it forward the haptic came loose.It was stated that injector went under the lens when the lens was being pushed out when the surgeon tried to push everything forward.
Event or Problem Description
A nurse reported with a description of loading issue and haptic leg broken with no patient harm.No further information expected as reporter unwilling to provide additional information.
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).

• 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: 22455778
• Report Number: 1119421-2025-01875
• Device Sequence Number: 8316506
• Product Code: KYB
• UDI-Device Identifier: 00380652394819
• UDI-Public: (01)00380652394819(17)270625(11)240626(10)15878851
• 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,Followup
• Report Date (Section B): 10/28/2025

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: 15878851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 10/03/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/29/2025; 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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 OVD
• Patient Sex: Unknown