MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT315
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that, during intraocular lens implantation surgery, the physician noticed white substance inside the lens.The physician attempted to remove he substance with irrigation and aspiration (i&a) but was unsuccessful.After the surgery, the physician examined the lens with the slit lamp and confirmed that the substance was not on the surface of the lens but was inside the lens.Additional information was requested, but no further information is available.
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that, the lens remains implanted in the patient's eye and there is no issues related to vision or other conditions.
Additional Manufacturer Narrative
The lens remains implanted.Two photos were provided of the eye.Photo #1 was a magnified photo of the pupil area.Three light reflections are observed to the right of: the image.Two are amber and one is white.A small white spot with irregular edges is observed to the left of these reflections.Photo #2 was a less magnified view of the eye.The small, irregular spot observed at the center of the image has been indicated as the area of interest by a red circle.The shape of the area may indicate lens damage.Damage to the company material can appear white under certain lighting conditions.No determination can be made without physical evaluation of the lens.A qualified cartridge was indicated with a non-qualified viscoelastic.It is unknown if a qualified handpiece was used.A root cause could not be determined for the "white spot".The lens remains implanted.A white spot was observed in the provided photos.The small, irregular spot observed at the center of the image has been indicated as the area of interest by a red circle.The shape of the area may indicate lens damage.Damage to the company material can appear white under certain lighting conditions.No determination can be made without physical evaluation of the lens.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Information was provided that the patient has not reported any issues.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
• 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: 17753865
• Report Number: 1119421-2023-01608
• Device Sequence Number: 6768285
• Product Code: POE
• UDI-Device Identifier: 00380652421645
• UDI-Public: 00380652421645
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023

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: 04/27/2026
• Device Model Number: DFT315
• Device Lot Number: 15195899
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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: BALANCED TIP & I/A TIP.; HAMERON INJ.(SODIUM HYALURONATE).; MONARCH III CARTRIDGE D.; OZIL TORSIONAL HANDPIECE.
• Patient Sex: Unknown