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

Model Number SN60AT

Device Problem Defective Component (2292)

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

Event Date 02/04/2020

Event Type  Injury  

Manufacturer Narrative

A sample product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that after an intraocular lens (iol) was implanted, the patient's vision was 20/50 with or without correction.A few days later the lens was exchanged in another facility by another surgeon.The vision was then 20/20.The patient then determined that the lens was at fault.Replacement lens information has not been provided.Additional information has been requested.

Manufacturer Narrative

Information was provided that the 16.5 diopter lens was replaced with a15.0 diopter lens.This may indicate the initial lens was not the diopter that the patient required.The manufacturer internal reference number is: (b)(4).

Event Description

In a follow up, the surgeon explained that almost a month after initial implantation, the patient went to another surgeon and had the first lens exchanged for another monofocal lens 1.5 diopters less power.The best corrected vision was then 20/20.

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10388839
• MDR Text Key: 202346653
• Report Number: 1119421-2020-01117
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: SN60AT
• Device Catalogue Number: SN60ATQ165
• Device Lot Number: 12706979
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR