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

Model Number MN60AC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Prolapse (2475); Zonular Dehiscence (2698)

Event Date 06/28/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.Attempts have been made to obtain additional information.(b)(4).

Event Description

A nurse reported that during a cataract extraction with intraocular lens (iol) implant procedure, the zonules prolapsed.The nucleus was stuck in the posterior bag and a vitrectomy was performed.Additional information provided by the initial reporter, that there was zonular dehiscence, which required an iol exchange and an anterior vitrectomy during the initial procedure.The iol was exchanged for a different model iol.The event resolved.In the surgeon¿s opinion the iol did not cause/contribute to the event.No explanation was provided.

Manufacturer Narrative

The product was returned.Solution was observed on the lens.Both haptics and optic damage observed.The root cause for the vitrectomy could not be determined.A malfunction has not been indicated or information provided that the lens was the cause of the event.(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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6895623
• MDR Text Key: 87446459
• Report Number: 1119421-2017-01160
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2017

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: 07/31/2018
• Device Model Number: MN60AC
• Device Catalogue Number: MN60AC.205
• Device Lot Number: 12246826
• Other Device ID Number: 00380655095126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 59