MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number	ZXT375
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens remains implanted.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that after implantation of a zxt375 14.5 diopter intraocular lens (iol), the patient had about 2.8d of astigmatism.The patient still has 1.7d left and their vision was terrible.The axis did not flip.In follow up with the physician it was noted there is no misalignment of the iol, retained viscoelastic, or dislocation/decentration of the iol.From looking at the post�-op data as is; it appears an iol exchange would need to be done.Through a later follow-up it was learned that the lens had rotated 10 degrees post implantation.The physician repositioned the iol on (b)(6) 2017 and the procedure went well.There were no more complaints from the patient and no plans for explant.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6589730
• Report Number: 9614546-2017-00463
• Device Sequence Number: 1278794
• Product Code: POE
• UDI-Device Identifier: 05050474606869
• UDI-Public: (01)05050474606869(17)220116
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/16/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U145
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention