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

Model Number SN6AT7

Device Problem Output Problem (3005)

Patient Problem No Code Available (3191)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the device was not returned for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.There have been no other complaints reported in the lot number.Additional information has been requested.(b)(4).

Event Description

A facilities representative reported an intraocular lens (iol) was exchanged as the diopter and power of lens was too high.The originally implanted lens was a 15.0 diopter lens.It was exchanged for a same model lens 13.5 diopter.Additional information was requested.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of a qualified cartridge and handpiece.Cartridge 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.Two viscoelastics were indicated, only one is qualified for this lens with the qualified cartridge combinations.The product investigation could not identify a root cause.(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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6749799
• MDR Text Key: 81241192
• Report Number: 1119421-2017-00971
• 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,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: SN6AT7
• Device Catalogue Number: SN6AT7U150
• Device Lot Number: 12507985
• Other Device ID Number: 00380652276351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2016
• 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: 42 YR