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

Model Number	DFT315
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.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 following an intraocular lens implant procedure, patient¿s reading and intermediate distances were better than expected.However, distance vision was bad and has not improved in the weeks after the procedure.The doctor wanted to wait and see if there is any improvement in another four weeks.Doctor suspected the intraocular lens may not have settled properly or there is an issue with the lens itself.Additional information was requested.
Event or Problem Description
Additional information was received stating patient sought a second opinion from another ophthalmologist.His opinion was that the lenses were fine and the surgeon had left some wiggle room with the lenses, that is patient was within an acceptable range and vision has improved 4 week post operation.Patient was started on another steroid and will be seeing me in a month.Surgeon still suggested that patient may need a lasik treatment for one of the eyes to improve the situation.
Additional Manufacturer Narrative
Correction information was provided in b.2, b.5 and b.6.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: 15804356
• Report Number: 1119421-2022-02429
• Device Sequence Number: 12165724
• Product Code: POE
• UDI-Device Identifier: 00380652421690
• UDI-Public: 00380652421690
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 04/17/2026
• Device Model Number: DFT315
• Device Lot Number: 15186773
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown