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

Model Number	ACU0T0
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that during an intraocular lens (iol) implantation procedure, he had to widen the incision for every suspect device used.The surgeon stated that the usual incision size was 2.4 mm, but this was not enough for the suspect device, so he had to widen the incision to 2.5 to 2.6 mm to insert the cartridge tip into the patient eye.There was patient contact, but no impact on the patient as the cataract operation was completed without any problems after the incisions were widened.There are seven medical device reports associated with this complaint.This report is 1 of 7.
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.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).Reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Corrected information provided in d.10., b.2.And h.6.Correction: on initial mdr the product problem code should have been a0203 instead of a24 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: LENS, GUIDE, INTRAOCULAR
• 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: 20292307
• Report Number: 1119421-2024-01897
• Device Sequence Number: 7209189
• Product Code: KYB
• UDI-Device Identifier: 00380652395250
• UDI-Public: (01)00380652395250(17)270221(11)240223(10)15805899(21)15805899073
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ACU0T0
• Device Lot Number: 15805899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/25/2024; 11/15/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/23/2024; 12/12/2024
• Date Device Manufactured: 02/23/2024
• 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: RED MANI KNIFE 2.2.; RED MANI KNIFE 2.4.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown