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

Model Number SN6AT6

Device Problem Positioning Problem (3009)

Patient Problem Visual Impairment (2138)

Event Type  Injury  

Event Description

An ophthalmic surgeon reported unsatisfied results after cataract surgery with intraocular (iol) lens implant.A year after surgery, he was not satisfied with the refraction and residual astigmatism.Additional information reported by a company representative.There was no subjective refraction performed postoperatively, but the patient was scheduled again to get this data.The surgeon did not want to perform an after-rotation or an explantation but rather tend to implant an additional iol into the sulcus.According to the surgeon, the patient was "extremely difficult." additional information has been requested.This is one of two reports being filed for the same patient.This file is for the patient's left eye (os).

Manufacturer Narrative

Evaluation summary: product history and batch records were reviewed and documentation indicated the product met release criteria.The root cause has not been identified.Additional information has been requested.(b)(4).

Event Description

Additional information received from an optician on behalf of the ophthalmologist indicated that the patient is now satisfied.

• 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: 4917528
• MDR Text Key: 6011065
• Report Number: 1119421-2015-05842
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6.160
• Device Lot Number: 11067171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2010
• 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
• Patient Age: 47 YR