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

Model Number SN6AT4

Device Problem Mechanical Problem (1384)

Patient Problem Visual Impairment (2138)

Event Type  malfunction  

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There were no other complaints reported in the lot number.Additional information was requested.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that following implantation of an intraocular lens (iol) patient experienced visual changes, anisometropia, was unable to tolerate and there was mechanical complication of lens.Additional information was requested.

Manufacturer Narrative

The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The lens was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified associated products were used.The root cause cannot be determined for the reported complaint.The initial reporter indicated that the intraocular lens was scheduled to be explanted on 12/21/2020, with a patient reason for explant of "visual changes", and a clinical reason for explant of "trouble tolerating, anisometropia, mechanical comp of lens".The lens was not returned.We are unable to confirm if the scheduled explant took place.Follow up attempts were made.No additional information has been provided at this time.If additional information becomes available or if the product returns, the file will be reopened and the investigation will be updated.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11072191
• MDR Text Key: 224400696
• Report Number: 1119421-2020-02018
• Device Sequence Number: 1
• Product Code: MJP
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.310
• Device Lot Number: 12511540
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1