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

Model Number SN6AT4

Device Problems Break (1069); Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

A customer reported that during an intraocular lens (iol) implant procedure, part of the haptic sheared or was torn off.The lens was left implanted and was later found to be malpositioned.The lens currently remains implanted with plans to exchange the lens.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.Attempts have been made to obtain additional information by phone and fax.A completed questionnaire was not received.(b)(4).

Event Description

Additional information was provided by a surgical coordinator, who reported that in the surgeon's opinion the iol was loaded incorrectly by the scrub tech, causing it to be inserted incorrectly with a broken haptic.The iol was observed to be malpositioned in the eye on the first postoperative day.This was no fault of the iol.The iol was exchanged for the same lens model and power two weeks later.

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The results from the product history record review indicated the product met release criteria.The product investigation could not identify a root cause.There are no other similar complaints for the lot.(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: janet moran ; 6201 south freeway; mail stop r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4723827
• MDR Text Key: 5580972
• Report Number: 1119421-2015-05185
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.265
• Device Lot Number: 12273550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2015
• Date Device Manufactured: 01/27/2014
• 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
• Patient Age: 73 YR