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

Model Number SN6AD1

Device Problem Material Distortion (2977)

Patient Problems Calcium Deposits/Calcification (1758); Vitreous Floaters (1866)

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the product was not returned for analysis.The lens remains implanted.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.Additional information has been requested.(b)(4).

Event Description

A consumer reported a triangle shape in her superior vision following an intraocular lens (iol) implant procedure.She indicated that her surgeon has told her she has calcifications and increase in floaters.Prk was performed.She never felt like her vision was what it should be and she can't see to trim her nails and the letters on the chart are distorted.The lens remains implanted.There are two medical device reports associated with this event.This report is associated with the right eye.

• Brand Name: ACRYSOF IQ RESTOR SINGLEPIECE IOL
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• 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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6217139
• MDR Text Key: 63693291
• Report Number: 1119421-2017-00003
• Device Sequence Number: 1
• Product Code: MFK
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: SN6AD1
• Device Catalogue Number: SN6AD1U155
• Device Lot Number: 12302924
• Other Device ID Number: 00380652241595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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
• Patient Outcome(s): Required Intervention