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

Model Number MN60AC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Blurred Vision (2137); Visual Impairment (2138)

Event Date 10/22/2018

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).

Event Description

A consumer reported that following an intraocular lens (iol) implant procedure, she experienced blurry, foggy vision and cannot see well enough to drive.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 8210155
• MDR Text Key: 131887584
• Report Number: 1119421-2019-00005
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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: 01/31/2022
• Device Model Number: MN60AC
• Device Catalogue Number: MN60AC.245
• Device Lot Number: 12522617
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR