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

Model Number SN6AT4

Device Problem Defective Component (2292)

Patient Problem No Code Available (3191)

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.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that following an intraocular lens (iol) implant procedure, the iol rotated out of position.Approximately six months postoperative, the iol was repositioned.Approximately twelve weeks later, the iol was removed due to a defective optic.The iol was replaced with a different lens model and a different power.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the lens was returned in a specimen cup.Viscoelastic is dried on the lens.The lens is cut into two pieces.Each portion has a cut/chipped area removed on the edge on each side of the optic cut.A scratch is also observed across the center of one portion.The lens dimensions were checked plan view and met specs except for the damaged areas.Power and resolution testing could not be checked due to the optic damage.Product history records were reviewed and the documentation indicated the product met release criteria.The root cause for the lens rotation cannot be determined.The specific optic defect was not identified.Optic damage is observed but we are unable to distinguish damage that may have occurred during the explant from damage that may be the reported optic defect.(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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 5903482
• MDR Text Key: 52972283
• Report Number: 1119421-2016-01210
• 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: 11/29/2016

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: 10/31/2019
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.160
• Device Lot Number: 12330629
• Other Device ID Number: 00380652250344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2014
• 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): Other; Required Intervention