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

Model Number SND1T3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Disturbances (2140)

Event Type  Injury  

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.There have been no other complaints reported in the lot number.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported following the intraocular lens implantation the patient had complained of glare and the lens was explanted in a secondary procedure.Additional information has been requested.There are two medical device reports associated with this patient.This report is for the right eye.

• Brand Name: ACRYSOF RESTOR TORIC SINGLEPIECE IOL
• Type of Device: 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: 14908925
• MDR Text Key: 295227461
• Report Number: 1119421-2022-01463
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SND1T3
• Device Catalogue Number: SND1T3.215
• Device Lot Number: 15059854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: REPLACEMENT LENS:DIBOO +22.5 D
• Patient Outcome(s): Required Intervention