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

Model Number	DFT015
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported the following after the phacoemulsification with intraocular lens (iol) implant procedure.The next day of implant, the visual acuity (va) was with a diaphragm of 0.6 and the pupil was 5.0 mm (postoperative mydriasis), the iol position was correct.Three weeks after, the patient complaints of decreased vision, especially near.Va is of 0.4 without correction, with correction with diaphragm 0.6 n/a, pupil 4.0mm.Decentered iol was noted, displaced downward and to the right relative to the center of the pupil.The centralization of the iol was performed.Iol centered on the pupil, without complications.On final examination (after iol centration), complaints of low vision at medium distance and near.Optical coherence tomography (oct) of the retina was without pathology.An electrophysiological examination revealed a conduction disturbance along the visual pathway.Right eye artifakia, and amblyopia.Suspected partial atrophy of the optic nerve.The patient was fitted with glasses for near +2.0, instillation of tear substitutes and non-steroidal anti-inflammatory drugs (nsaids).
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).
Additional Manufacturer Narrative
The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Follow up information was provided that all is well with the patient.The patient complaints have stopped ucva od = 0.8.The patient has adapted and is now satisfied with the visual acuity.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, everything is fine with the patient.Currently the patient sees well with this eye.Complaints have been stopped.The patient has adapted and is now satisfied with the visual acuity with the implanted iol.

• 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: 15788162
• Report Number: 1119421-2022-02408
• Device Sequence Number: 14889847
• Product Code: POE
• UDI-Device Identifier: 00380652421218
• UDI-Public: 00380652421218
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

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: 08/04/2026
• Device Model Number: DFT015
• Device Lot Number: 15240277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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 Age: 75 YR
• Patient Sex: Male