MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	ACU0T0
Medical Device Problem Codes	Device Damaged by Another Device (2915); Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2024
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implant procedure, the lens was implanted into the eye when the doctor was positioning the lens and noticed a scratch.The lens was removed.The second and third lens were jammed in the cartridge.The fourth lens was implanted successfully.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The device and the lens were returned.The lens was returned on a piece of folded white material.Viscoelastic was observed on the lens.The optic was cut into two pieces, typical of an insertion and removal.Both optic portions have scratches and small cracked areas.One optic portion has lines of cracked damage in the shape of an instrument used to grasp the lens beginning at the optic edge and extending inward.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The reported scratch was observed.The root cause cannot be determined for the reported complaint.The lens was cut into two pieces, typical of an insertion and removed.Cracked damage was also observed.The plunger was retracted upon return.It is unknown if a delivery difficulty occurred prior to implanting.The plunger position in relation to the lens during advancement cannot be determined.The instructions for use (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.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20736058
• Report Number: 1119421-2024-02262
• Device Sequence Number: 12856285
• Product Code: HQL
• UDI-Device Identifier: 00380652395328
• UDI-Public: (01)00380652395328(17)260614(11)230616(10)15659148
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 02/11/2025

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 Expiration Date: 06/14/2026
• Device Model Number: ACU0T0
• Device Lot Number: 15659148
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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: ACRYSOF ULTRASERT DELIVERY SYSTEM; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 86 YR
• Patient Sex: Female