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

Model Number ASKU

Device Problem Material Opacification (1426)

Patient Problems Vitreous Floaters (1866); Retinal Tear (2050); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A non health care professional reported that following an intraocular lens (iol) implant procedure, the patient seems that looking through smudged lenses that was really intensified in certain lighting.The patient had many floaters.In the past couple of years she developed a tear in retina, which was treated with laser.The patient was very frustrated with trying to see through cloudy lenses which reminds that dirty finger prints on glasses lenses.Additional information has been requested.

Manufacturer Narrative

It is unknown if both eyes had an company lens.The associated products information was not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.Information was provided that lenses were implanted before the patient was 40 years old.Patient is now 61 years old.Gradual development of symptoms starting 10 years after implant.The file indicates that the patient had cataract in both eyes but it is not known, whether both eyes had company lenses.This file was created to capture the available event and information.Follow up attempts were made.No further information has been provided to date.If further information becomes available identifying that an company iol (intraocular lens) was implanted into the patient's other eye, an additional file will be created for the bilateral eye.This file will also be reopened and updated if additional event details become available.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF 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 ; 8007579780
• MDR Report Key: 13017078
• MDR Text Key: 282327227
• Report Number: 1119421-2021-02401
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female