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

Model Number SN6AT3

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

Patient Problems Calcium Deposits/Calcification (1758); Visual Impairment (2138)

Event Date 01/15/2019

Event Type  Injury  

Manufacturer Narrative

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.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer has reported that she has poor distance vision after undergoing cataract surgery with an intraocular lens implant.She can see great at near and intermediate ranges, but anything farther than 6 feet is unclear.She states her lens was supposed to be for distance vision and her doctor states that is what he gave her despite her results.Additional information was provided by the surgeon, who indicated that he is uncertain what caused or contributed to the event.The aberrometer calculated iol power to be approximately.25-.50.The postoperative refraction was a -2.00 sph.The prognosis is excellent as the other eye is focused at distance.To date the patient is happy with unplanned monovision.Posterior capsular opacification has been observed.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - 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: 8370297
• MDR Text Key: 137152559
• Report Number: 1119421-2019-00230
• Device Sequence Number: 1
• Product Code: MJP
• 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
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.270
• Device Lot Number: 12584626
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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: MONARCH CARTRIDGE; PROVISC; VISCOAT
• Patient Outcome(s): Other
• Patient Age: 76 YR