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	02/20/2025
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 healthcare professional reported that during cataract surgery with intraocular lens (iol) implant procedure, the surgeon noticed that one of the haptics of the lens was broken.The procedure was completed with unspecified replacement iol.Additional information received stating that there was no patient contact.
Additional Manufacturer Narrative
The device with the lens was returned.The lens stop and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was dried in the device.The plunger has advanced the lens to the fill line and was in contact with the trailing optic edge.The trailing haptic was misfolded in the gusset area and located in the optic fold.The leading haptic was extended into the nozzle tip and broken at the distal haptic tip at the nozzle tip exit.The optic was scraped on the anterior surface along the optic center and left side.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.The lens was further evaluated after removal from the nozzle.The optic trailing portion was torn and split, similar in appearance to a plunger override.The optic left side was broken and positioned on top of optic.The right side of the optic was torn and split.Based on the returned plunger position against the trailing optic edge, this suggests a plunger retraction and additional delivery attempt.Topcoat dye stain testing was conducted with acceptable results.Product history records were reviewed, and the documentation indicated the product met release criteria.A qualified viscoelastic was used.The returned used device was inspected.The root cause cannot be determined for the reported complaint.Two issues were observed.The reported broken haptic damage was observed.The leading haptic was extended and the distal haptic tip was broken at the nozzle tip exit.In addition, the trailing haptic was misfolded and optic damage was observed, combined suggestive of a previous plunger override.Based on the plunger in contact with the optic edge upon return, this may suggest that a plunger retraction and a second delivery attempt was made.It is possible that a plunger override may have impacted the leading haptic position and condition.Plunger override may occur: due to rapid advancement faster than the instructions for use (ifu) recommended rate.If the operating room temperature is too high (more than 23 degree celsius / 73-degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent, and this may inhibit lens advancement.Topcoat dye stain testing was conducted with acceptable results.File will be reopened if new information is received.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: 21676643
• Report Number: 1119421-2025-00795
• Device Sequence Number: 18200348
• Product Code: HQL
• UDI-Device Identifier: 00380652394826
• UDI-Public: (01)00380652394826(17)270422(11)240423(10)15842811
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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: 15842811
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.; UNSPECIFIED REPLACEMENT IOL.
• Patient Sex: Unknown