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

Model Number MA60AC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Corneal Edema (1791)

Event Date 12/25/2020

Event Type  Injury  

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 customer reported one day post implant of an intraocular lens (iol), a patient developed corneal edema.The patient reported he rubbed his eyes.He was given symptomatic treatment.Additional information was requested.

Manufacturer Narrative

The product was not returned.Product history records were reviewed, and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown, if qualified products were used.The reported lens model is only qualified for use in the company (a) and (b) cartridges.The product investigation could not identify a root cause.According to the patient's self-report, he rubbed his eyes, during the period.And was given symptomatic treatment in time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11204812
• MDR Text Key: 227872967
• Report Number: 1119421-2021-00109
• 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,other
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: MA60AC
• Device Catalogue Number: MA60ACC210
• Device Lot Number: 12699074
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention