MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ RESTOR SINGLEPIECE IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	SV25T0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	12/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A ophthalmic surgeon reported following an intraocular lens (iol) implant procedure, patient is experienced glares and halos around letters when reading signs while driving.She also reports seeing a gray outline around letters.Patient has noticed an improvement since her 1 week post operation visit.Additional information has been requested and received that the surgery occurred on 27 apr 2022.Viscoelastic was used to expand the capsule and float the intraocular lens into the anterior chambers.The lens was cut in half using forceps and scissors.Eye drops were recommended.Symptoms were resolved.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.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.Information was provided that the patient was experiencing glares and halos around letters when reading signs while driving.Patient noticed an improvement since the 1 week post operation visit.Updated information: the company lens was removed and replaced with a non-company lens.There are no other complaints in this lot.The manufacturer internal reference number is:(b)(4).

• Brand Name: ACRYSOF IQ RESTOR SINGLEPIECE IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 14786420
• Report Number: 1119421-2022-01359
• Device Sequence Number: 14715069
• Product Code: MFK
• UDI-Device Identifier: 00380652307765
• UDI-Public: 00380652307765
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2022

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: 06/30/2024
• Device Model Number: SV25T0
• Device Catalogue Number: SV25T0U210
• Device Lot Number: 12728521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2019
• 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: MST FOCEPS AND SCISSORS; UNSPECIFIED OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female