MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFAT40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Retinal Detachment (2047); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Dizziness (2194); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient complaint of decreased vision.The decreased vision was at a distance and constant and associated with foreign body sensation and photophobia.The decreased vision has been present for 1 week and patient being treated lubricate dry eyes and anti-inflammatories.In post off 2nd visit patient complaint of foreign body sensation.The yag (yttrium aluminum garnet) laser posterior capsulotomy performed for posterior capsular opacification.Post yag patient complaint about intermediate was blurry and has trouble focusing, causing dizziness.The lens was explanted in a secondary procedure.Additional information was received stating patient had complicated cataract extraction with intraocular lens (iol) implant procedure initially.Patient had an explant, anterior vitrectomy, inferior fovea splitting rhegmatogenous retinal detachment (rrd).Followed by a pars plana vitrectomy and patient now doing well.
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).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• 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: 14907325
• Report Number: 1119421-2022-01455
• Device Sequence Number: 5062363
• Product Code: MFK
• UDI-Device Identifier: 00380652419208
• UDI-Public: 00380652419208
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/04/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2025
• Device Model Number: TFAT40
• Device Catalogue Number: TFAT40.185
• Device Lot Number: 15050018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 07/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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: OCUFLOX; PREDNISOLONE; PROLENSA; UNSPECIFIED VISCOELASTICS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male