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

Model Number SND1T5

Device Problem Material Discolored (1170)

Patient Problem Visual Impairment (2138)

Event Date 12/08/2021

Event Type  malfunction  

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.(b)(4).

Event Description

A physician reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient observes a change in the coloration of the lens, green was observed.The visual acuity in the post surgical was 20/20 and on (b)(6) 2021, was 20/40.The patient reported a difference in visual quality with respect to the contrast of colors between both eyes.Additional information has been requested.

Manufacturer Narrative

The lens remains implanted.Information was provide that the lens will not be explanted; the patient is stable; with vision 20/40; reports a decrease with respect to the postoperative result, which was initially 20/20.The lens was reported implanted eight years ago.The manufacturer internal reference number is: (b)(4).

• 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: 13119356
• MDR Text Key: 282976491
• Report Number: 1119421-2021-02515
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: SND1T5
• Device Catalogue Number: SND1T5.185
• Device Lot Number: 11037792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1