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); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported with a description, intraocular lens (iol) could not be implanted.Additional information was received and stated, during iol implantation, the haptic became jammed between the cartridge tip and the injection plunger.It could not be released even by carefully retracting and then advancing the plunger.When the pre-load device tip was withdrawn from the cut, the haptic tore off just above the optics and remained in the cartridge.The cause in the opinion of the operator due to a quality defect of the pre-load device.The procedure was not completed, no hospitalization was necessary due to the event and there was no patient harm.
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).
Additional Manufacturer Narrative
Additional information was provided in b5.The manufacturer's internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated, the patient was in good health condition and nothing further was planned.
Additional Manufacturer Narrative
Additional information was provided in h.3.,h.6 and h.11.The device and a broken haptic were returned in an opened noncompany pouch.The lens stop and plunger lock were removed.The plunger was oriented correctly.Viscoelastic was dried in the device.The plunger was fully advanced.The trailing haptic distal tip was smashed and broken on the left side of the plunger in the nozzle tip.The remainder of the broken haptic was returned inside the pouch.The optic and leading haptic were not returned.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified viscoelastic was used.The root cause could not be determined for the broken haptic.The trailing haptic tip was smashed and broken in the tip on the left of the plunger.The remainder of the broken haptic was returned outside of device.The plunger position in relation to the broken haptic during advancement cannot be determined.Information was provided that the haptic became jammed between the tip and plunger.The information indicated that the plunger was retracted and advanced in an attempt to free the lens.This is not a recommended practice.The ifu instructs: after the lens has been advanced to the fill-to line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.No part of the lens should exit the nozzle prior to insertion through the incision.Once the lens is in position at the fill-to line, it should be implanted within 3 minutes.Proceeding with implantation of a misfolded haptic or a lens that appears to be out of position can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and or pinched and sheared by the moving plunger.Broken haptics may occur: 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.In addition, haptic strength (modulus) decreases as the temperature increases and is more likely to break under stress.If a straight trailing haptic occurs and it was not properly detected to be out of position.If the plunger is not fully advanced, or if the plunger is allowed to retract, the trailing haptic may not release properly from the device.Any of the above listed causes alone, or in combination, may create the reported event follow up was provided that indicated after the haptic became jammed between the tip and plunger, the plunger was retracted and advanced to attempt to release the haptic.The follow up also indicated that when the cartridge tip was withdrawn from the cut, the haptic tore off just above the optics and remained in the cartridge.The retraction of the plunger followed by attempts to advance or release the lens is not a recommended practice per the instructions for use (ifu).Per the ifu: gently advance the plunger in one smooth, continuous motion to deliver the intra ocular lens (iol).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: 21864136
• Report Number: 1119421-2025-01094
• Device Sequence Number: 20812402
• Product Code: KYB
• UDI-Device Identifier: 00380652394727
• UDI-Public: (01)00380652394727(17)270916(11)240917(10)15917793
• 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,Followup
• Report Date (Section B): 07/04/2025

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: 15917793
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 06/11/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/21/2025; 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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
• Patient Age: 75 YR
• Patient Sex: Male