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

Model Number MA60AC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Intraocular Pressure Increased (1937); Pain (1994); Swelling (2091); Fluid Discharge (2686)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The product investigation could not identify a root cause.Information was provide that the lens was implanted (b)(6) 2017.Reported events occurred and were treated on (b)(6) 2017.Patient was released (b)(6) 2017.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

Following an intraocular lens (iol) implant procedure, a customer reported a patient experiencing swelling, pain, edification of aqueous humor, intraocular pressure (iop) increased, and fluid discharge through the anterior chamber.Medication was used.The patient presented as stable two days following the implant.

Manufacturer Narrative

This supplement is being filed to correct the value to adverse event and product problem.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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7846008
• MDR Text Key: 119222043
• Report Number: 1119421-2018-01258
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: MA60AC
• Device Catalogue Number: MA60ACC120
• Device Lot Number: 12448662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2016
• 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; Required Intervention