MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SA60AT

Device Problem Insufficient Information (3190)

Patient Problems Visual Impairment (2138); Reaction (2414)

Event Date 06/10/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis; the lens remains implanted.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.Additional information has been requested.Zip code is not indicated at this time.(b)(4).

Event Description

A surgeon reported increased incidence of dimness of vision in patients 2 to 5 weeks following intraocular lens (iol) implant procedures.The probable cause is the eyes reaction to the lens material on tapering of steroids leading to an iritis or cystoid macular edema.There are 6 medical device reports associated with the events reported.This report is for the 3rd of 6 incidents.

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6714245
• MDR Text Key: 80056875
• Report Number: 9612169-2017-00125
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.225
• Device Lot Number: 21178379
• Other Device ID Number: 00380652555852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2017
• Date Device Manufactured: 11/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other