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

Model Number SN60WF

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A facility representative reported an intraocular lens (iol), with a description of "lens was warped/deformed at edges".There was no patient contact and the procedure was completed the same day.Additional information was requested.

Manufacturer Narrative

The product was not returned.All product and batch history records are quality reviewed prior to product release.Associated products were not provided.It is unknown if qualified products were used.The reported lens is only qualified for use in the company(a) and (b) cartridges the product investigation could not identify a root cause.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: 9539904
• MDR Text Key: 178108645
• Report Number: 1119421-2020-00012
• 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: other
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.260
• Device Lot Number: 12662535
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1