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

Model Number	DFT015
Medical Device Problem Codes	Defective Component (2292); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non health care professional reported following implantation of intraocular lens (iol), the patient experienced cloudy vision.The lens was explanted in a secondary procedure.Additional information has been received and there was a quality issue with the lens that caused or contributed to the event indicating lens not centered, possible damage to haptic.The lens was exchanged with another lens model.
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
Patient¿s issues have been resolved.Doctor¿s prognosis was indicated as good.
Additional Manufacturer Narrative
Patient's issues have resolved and the surgeon's prognosis is good.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction g.3: supplemental medical device report (smdr) # 02 is being filed to correct the g.3 date on the supplemental report, filed earlier.Incorrect date of 22-sep-2022 is being corrected to 11-nov-2022.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY 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: 15632302
• Report Number: 1119421-2022-02225
• Device Sequence Number: 12771316
• Product Code: POE
• UDI-Device Identifier: 00380652421157
• UDI-Public: 00380652421157
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2025
• Device Model Number: DFT015
• Device Lot Number: 15038942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 01/09/2023
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 12/07/2022; 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2020
• 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: DUOVISC; MONARCH III CARTRIDGE D; MONARCH III IOL INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male