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 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

The product was returned.Solution was dried on the lens.Both haptics were in an acceptable folded position, typical in appearance of being loaded into a cartridge.The lens was cleaned with lphse for further evaluation.The lens unfolded with no abnormalities.A dimensional inspection was conducted.The lens met specifications per the approved (plan view) template.The lens is not "misshaped." all product and batch history records are quality reviewed prior to product release.The product investigation could not identify a root cause for the reported complaint.A dimensional inspection was conducted.The lens met specifications per the approved (plan view) template.The lens is not "misshaped." there is one other complaint in the lot.This product malfunction was originally reported under an alternative summary report ((b)(4)).The sample has been returned and investigation was updated, which prompts evaluation and conclusion coding to be updated.As the alternative summary report (b)(4) has been revoked, the updated information (product investigation and coding) is being sent via this 3500a report.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that an intraocular lens was misshapen.Another lens was implanted instead.

• 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: 9919435
• MDR Text Key: 187263565
• Report Number: 1119421-2020-00597
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/03/2020

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: 07/31/2023
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.205
• Device Lot Number: 12643624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2020
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2018
• 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