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

Model Number SN6AT6

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

Patient Problems Iritis (1940); Red Eye(s) (2038); Excessive Tear Production (2235); Eye Pain (4467)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A consumers wife reported that following a cataract surgery with an intraocular lens (iol) implantation, her husband is experiencing problems/adverse events with an iol.Additional information was provided indicating that her husband's right eye seems to be red and watery.He has seen the doctor and they didn't see anything wrong with the lens but thought he may have slight irritation and provided him antibiotic drops.She reported that his symptoms are recent and after surgery he was fine and did not have any concerns.He is not having any visual concerns.Additional information was provided by the consumer's wife who reported that her husband has had several more attacks of very pain and a very red eyeball.The doctor determined that he has iritis.He prescribed steroid eye drops.

• Brand Name: ACRYSOF IQ 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 ; 8175514979
• MDR Report Key: 11873949
• MDR Text Key: 252302356
• Report Number: 1119421-2021-01087
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652274920
• UDI-Public: 00380652274920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6U230
• Device Lot Number: 12537366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention