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

Model Number	DFT315
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/01/2023
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following the iol implantation procedure, observed a non-cellular lens fogging visible on the iol with decreasing reading vision.It was on the frontside of the lens, looks like a fingerprint (but definitely was not).Additional information received and stated that, the patient experiences more difficulty reading.
Additional Manufacturer Narrative
The lens remains implanted.A photo was provided.The photo was reviewed by global quality customer affairs (gqca).Synopsis: the cornea appeared clear without anomaly.The anterior chamber appeared deep and quiet.The iris was dilated with an approximate 9 to 10 mm round pupil.The view through the pupil revealed the following features: a well-centered pc iol apparently located anterior to the anterior lens capsule, suggested by the reflection of the iol edge.A vertically oriented, approximately 0.5mm h x 2mm w, light, amber-colored translucent anomaly located roughly 2mm directly inferior from the optical center.This finding appears to be positioned either between the anterior capsule and iol or anterior to the iol.A vertically oriented, approximately 1mm h x 4-5mm w, gray/white-colored opacity.The superior edge was located slightly to the right and above the optic center, with the remainder of the opacity extending directly inferior.This finding appears to be positioned behind the anterior capsulorhexis opening.An irregular, mottled, approximately 2mm h x 3-4mm w, amber-colored translucent anomaly positioned posterior to the gray/white-colored opacity and immediately to the right of the optical center.The posterior lens capsule was in poor focus and, vitreous and retina are out of focus and not visible.A red fundus reflex was not present.The root cause for the reported ¿fogging¿ could not be determined.The lens remains implanted.Review of the provided photo was inconclusive.A vertically oriented, gray/white-colored opacity was observed.The superior edge was located slightly to the right and above the optic center, with the remainder of the opacity extending directly inferior.This finding appears to be positioned behind the anterior capsulorhexis opening.Other anomalies were observed.Based on the reported description the gray/white-colored opacity captured may represent the reported non-cellular lens fogging.However, based solely on the analysis of this photograph, the identity of these findings and their locations within the eye cannot be definitively determined, and therefore, the reported event cannot be conclusively confirmed.Information was provided on follow-up that doctor notices little patient impact, policy: wait and see.No explant is planned at this time.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: 17779726
• Report Number: 1119421-2023-01622
• Device Sequence Number: 14820977
• Product Code: POE
• UDI-Device Identifier: 00380652421584
• UDI-Public: 00380652421584
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 11/28/2023

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 Model Number: DFT315
• Device Lot Number: 15308162
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 11/05/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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: HEALON PRO.
• Patient Sex: Unknown