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

Model Number SN60WF

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 05/20/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the lens was returned loose in a biohazard bag with the base of the lens case inside the opened lens carton.Solution was dried on the lens.One haptic is broken in the distal area.The broken distal portion was returned.The optic is broken/torn into two portions.Both portions were returned.Additional torn/split areas of damage were observed to the optic portions.Optic edge damage was also observed.All product and batch history records are quality reviewed prior to product release.A qualified cartridge and viscoelastic were used with the lens.Haptic and optic damage was observed.Also the optic was in pieces typical to damage from insertion and removal.Based on information provided by the implanting facility, the root cause for the complaint of "lens looked folded" is unrelated to the product.The facility indicated that there was no issue with the lens or cartridge, it was a loading error by the tech.The specific technician error was not indicated.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

An inventory coordinator reported that during an intraocular lens (iol) implant procedure, the "lens looked folded".The incision was enlarged to remove the iol.The procedure was completed.Additional information was provided indicating that there was no issue with the lens or cartridge.It was a loading error by the tech.

• 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
• 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: 10192908
• MDR Text Key: 196394077
• Report Number: 1119421-2020-00894
• Device Sequence Number: 1
• Product Code: HQL
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2020

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 Model Number: SN60WF
• Device Catalogue Number: SN60WF.205
• Device Lot Number: 12749776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2019
• 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
• Patient Age: 63 YR