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 Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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.Three photos were provided.Photo #2 is the iol labeling.Photo #3 is a drawing indicating the area of interest.Photo #1 was reviewed based on the drawing.Photo #1: this photo shows an implanted single-piece monofocal lens.The "fiber" indicated on the drawing was visible.This appeared to be under the lens, near one optic/haptic junction area.The material was elongated and had a curved portion at the end resembling a backwards question mark.The origin and nature of the material cannot be determined from the photo.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An ophthalmic surgeon reported about a fiber within the iol was noticed after intraocular lens implantation which was not visually significant.Additional information has been requested and received stating in surgeon's opinion, the fiber in lens was during the manufacturing process.
Additional Manufacturer Narrative
As the suspect device is a preloaded delivery system, the associated products cartridge and injector previously reported in d.10.Are in error.The manufacturer internal reference number is: (b)(4).

• 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: 16867116
• Report Number: 1119421-2023-00836
• Device Sequence Number: 5460295
• Product Code: HQL
• UDI-Device Identifier: 00380652395236
• UDI-Public: 00380652395236
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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: 03/13/2025
• Device Model Number: ACU0T0
• Device Lot Number: 15372230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 66 YR
• Patient Sex: Male