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

Model Number SN6AT7

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 07/16/2015

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, email and fax.A completed questionnaire was not received.(b)(4).

Event Description

A customer reported that following an intraocular lens (iol) implant procedure, the patient experienced poor vision due to the cylinder power being to high.The iol was exchanged.Additional information has been requested.

Manufacturer Narrative

(b)(4).

Event Description

Additional information was provided by the surgeon, who reported that the event resolved with treatment.The patient's cylinder axis flipped, unclear etiology.Additional information has been requested.

Manufacturer Narrative

Evaluation summary: the product was not returned.The product history records were reviewed and the documentation indicated the product met release criteria.The customer indicated the use of an approved cartridge and handpiece.The cartridge and handpiece 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.A viscoelastic was indicated which is not qualified for the lens/cartridge combination used.The product investigation could not identify a root cause.The replacement lens was not provided.(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: 5378409
• MDR Text Key: 36344984
• Report Number: 1119421-2016-00118
• 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: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: SN6AT7
• Device Catalogue Number: SN6AT7U205
• Device Lot Number: 12347998
• Other Device ID Number: 00380652276467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2015
• 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: 75 YR