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

Model Number SN6AT4

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Capsular Bag Tear (2639)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.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.Attempts have been made to obtain additional information by phone and email.A completed questionnaire was not received.(b)(4).

Event Description

A nurse reported that a capsule tear occurred during an intraocular lens (iol) implant procedure.The capsule tear was observed after the iol was placed in the eye.The lens was removed and the procedure was completed with another lens.According to the nurse, the surgeon stated that there was no problem with the iol.The sample is not available additional information has been requested.

Manufacturer Narrative

Evaluation summary: the product was not returned.The customer indicated the use of an unspecified cartridge and an unspecified handpiece.The customer also indicated the use of a viscoelastic, which is not qualified for the approved lens/cartridge combinations for this lens model.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause for the capsular tear 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 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: 5258719
• MDR Text Key: 32436092
• Report Number: 1119421-2015-06714
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.180
• Device Lot Number: 12108965
• Other Device ID Number: 00380652250382
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2012
• 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
• Treatment: UNKNOWN HANDPIECE
• Patient Outcome(s): Other
• Patient Age: 80 YR