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

Model Number SND1T3

Device Problem Positioning Problem (3009)

Patient Problem Visual Disturbances (2140)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

A sample product was not returned for analysis.The iol product history records were reviewed and documentation indicates the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.(b)(4).

Event Description

A surgeon reported that two months after an intraocular lens (iol) was implanted, it had to be repositioned due to being off axis.One month later a yag capsulotomy was performed.At that time the patient had very good distance and near vision without correction.The surgeon did not see the patient for almost 2 years until recently when the patient returned with a complaint of decreased uncorrected near vision, yet the distance vision is very good.The near vision does improve with correction, but is still not as good as it was 2 years prior.The surgeon does not know what could be the cause of the vision change.The patient's retinal exam did not show concern.

• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8650427
• MDR Text Key: 146414862
• Report Number: 1119421-2019-00786
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: SND1T3
• Device Catalogue Number: SND1T3U105
• Device Lot Number: 12521832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC; MONARCH D CARTRIDGE
• Patient Outcome(s): Required Intervention