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

Model Number SN60WF

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Blurred Vision (2137); Visual Impairment (2138)

Event Date 07/13/2018

Event Type  Injury  

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.Additional information has been requested.(b)(4).

Event Description

A consumer reported that following a bilateral glaucoma filtration device and intraocular lens (iol) implant procedure, her vision was blurry at near and distance.She reported her vision is distorted and does not feel comfortable driving, especially at night.A laser procedure was performed reported and her vision is better.There are multiple reports for this event.This report is for the left eye.

Manufacturer Narrative

Product evaluation: the product was not returned.All product and batch history records are quality reviewed prior to product release.Root cause: the product investigation could not identify a root cause for the reported events.The patient reported blurry distance vision and fair near vision.The iol is a monofocal iol which only corrects for near or far per the refraction targeted by the surgeon.The patient has indicated their vision improved after the capsulotomy procedure.The patient has reported visual issues with both eyes.The fellow eye is implanted with a toric iol.The patient was contacted by a director of global quality customer affairs to discuss their concerns.A malfunction was initially reported in b.2., but was reported in error.Additional information provided in h.3.And h.10.Corrected information provided in h.10.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in a.2., b.6., b.7.And d.11.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10303468
• MDR Text Key: 199734004
• Report Number: 1119421-2020-01030
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.220
• Device Lot Number: 12614998
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 09/16/2020; 10/27/2020
• Supplement Dates FDA Received: 10/06/2020; 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CYPASS SYSTEM 261-S US, CYP.; FEMTO LASER.; CYPASS SYSTEM 261-S US, CYP
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR