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

Model Number SN6AT5

Device Problem Material Integrity Problem (2978)

Patient Problems Blurred Vision (2137); Visual Disturbances (2140)

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.Additional information has been requested.(b)(4).

Event Description

A consumer reported that after having an intraocular lens (iol) implant procedure, the consumer experienced trouble seeing.An iol rotation was performed.The consumer was informed that the lens was warped by a second physician.Additional information was provided by a certified ophthalmic technician, who reported that the patient had experienced blurred/distorted vision.The implanting surgeon had repositioned the lens once and the vision was only stable for short while before going back out of focus.The current physician performed an exchange and the patient is seeing well.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Product evaluation: the lens was returned by the patient loose in a plastic bag.Solution is dried on the lens.The lens does not appear to be warped.The lens was cleaned with lphse.The optic is cut from the edge to the center (typical of removal).Small cracked areas were observed which appear to have been caused by an instrument used to grasp the lens.The lens dimensions were acceptable (plan view) using an approved template.The root cause for the reported "warped lens" cannot be determined.Lens damage was observed, which can most likely be attributed to the removal procedure.The report of warped appears to be in relation to the lens position in the eye.Information was provided that surgeon repositioned the lens once and the vision was only stable for short while before going back out of focus.This could indicate a lens rotation.Per the directions for use (dfu): misalignment of the axis of the lens with the intended axis of placement may compromise its astigmatic correction.Such misalignment can result from inaccurate keratometry or marking of the cornea, inaccurate placement of the toric iol axis during surgery, an unanticipated surgically induced change in the cornea, or physical rotation of the toric iol.(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: 6527506
• MDR Text Key: 73892459
• Report Number: 1119421-2017-00572
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.190
• Device Lot Number: 12329125
• Other Device ID Number: 00380652250979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2014
• 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: 66 YR