MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT4

Device Problems Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017); Component or Accessory Incompatibility (2897)

Patient Problem No Code Available (3191)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

The device was received by a company representative and is in transit to the manufacturing site for investigation.Investigation including root cause analysis will be completed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The iol product history records were reviewed and documentation indicates the product met release criteria.There have been no other complaints reported in the lot number.Attempts have been made to obtain additional information.A completed questionnaire was received on 11/09/2015.(b)(4).

Event Description

A facility representative reported that an intraocular lens (iol) had a haptic failure.In a follow up, a facility director indicated that the haptic failure was noted six weeks after initial implantation and was then exchanged approximately one month later.The director reported an unapproved lens/handpiece/viscoelastic combination used during iol implantation.

Manufacturer Narrative

A sample lens was not received for analysis.The product investigation could not identify a root cause.Information was provided which indicated an unapproved handpiece with an unapproved viscoelastic were used.The use of unapproved products may result in lens delivery difficulties or lens damage.(b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5268465
• MDR Text Key: 32742219
• Report Number: 1119421-2015-06740
• Device Sequence Number: 1
• Product Code: MJP
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.235
• Device Lot Number: 12270507
• Other Device ID Number: 00380652250498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2014
• 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: 68 YR
• Patient Weight: 84