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

Model Number	DFT315
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that lens was defective.Additional information was requested.
Additional Manufacturer Narrative
The lens was returned inside the qualified company cartridge with the disassembled lens case inside the opened lens carton.Inadequate viscoelastic was observed in the cartridge.The lens was located between the loading area and the nozzle entry area.The lens was positioned incorrectly, pressed up instead of down per the ifu(instructions for use).The leading haptic was folded back under the optic.The trailing haptic was extended backward along the interior ceiling of the cartridge.The cartridge wings displayed evidence of handpiece use.The cartridge was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.The handpiece and viscoelastic information was not provided.It is unknown if qualified products were used with this lens/cartridge combination.The complaint was reported as ¿defective¿.The lens was returned positioned incorrectly in the cartridge.This was most likely interpreted as the reported complaint.The root cause for the reported complaint may be related to a failure to follow the ifu.The lens was pressed up, instead of biased down inside the cartridge.The ifu instructs: the lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Failure to follow this step may cause the lens to advance incorrectly causing delivery issues and/or damage.Also, an inadequate amount of viscoelastic was observed in the cartridge.The ifu also instructs to completely fill the cartridge with ovd (diagram provided) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd(ophthalmic viscosurgical device) in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.Top coat dye stain testing was conducted with acceptable results.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated that, the lens was not implanted because the capsule was broken, occurred during surgery, when injecting the lens surgery was completed with a second lens.

• 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: 15650382
• Report Number: 1119421-2022-02246
• Device Sequence Number: 16733407
• Product Code: POE
• UDI-Device Identifier: 00380652421607
• UDI-Public: 00380652421607
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2026
• Device Model Number: DFT315
• Device Lot Number: 15194022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 11/30/2022; 05/05/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 12/22/2022; 05/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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: MONARCH III IOL CARTRIDGE D.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown