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

Model Number	SND1T4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	08/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported following the intraocular lens implantation the patient had experienced distance, near and computer vision are all blurry.Also has glare issues in the day and night.Hence the lens was explanted in a secondary procedure and replaced with another lens of different company.There was no harm to the patient and the prognosis was also good.It was also reported that a goniotomy and limbal relaxing incisions were also performed.The patient was not hospitalized for the event.There are two medical device reports associated with this patient.This report is for the left eye.
Additional Manufacturer Narrative
The explanted lens was returned inside a small plastic specimen jar.Dried solution was observed on the lens.The lens was cleaned with klrp for further evaluation.One haptic was broken in the gusset area.The broken haptic was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.There have been no other complaints reported in the lot number the root cause cannot be determined for the reported complaint.The explanted lens was returned.No damage was observed.Information was provided in the file that the multifocal lens of 9.5 diopter was removed and replaced with a monofocal lens model 10.5 diopter.The replacement lens model does not have a toric component.The information that a multifocal toric lens was exchanged for a monofocal non-toric lens would reasonably suggest that the complaint may not be related to the iol.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF RESTOR TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 14641847
• Report Number: 1119421-2022-01220
• Device Sequence Number: 4842227
• Product Code: MJP
• UDI-Device Identifier: 00380652270410
• UDI-Public: 00380652270410
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2022

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: 12/31/2021
• Device Model Number: SND1T4
• Device Catalogue Number: SND1T4U095
• Device Lot Number: 12516730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2017
• 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: CZ70BD 10.5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 91 KG