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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, not provided.Date of event: unknown, was not provided.If explanted, give date: not applicable as the lens remains implanted.All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a patient had a cataract surgeries done (b)(6) 2016, and (b)(6) 2017.The patient is reporting that their near vision is now worse then ever, particularly in the left eye which seems to have developed a permanent grey cloud affecting both near and far vision.Patient also stated that their near vision was better prior to the surgeries.The patient expected to be able to read without magnifiers after the lenses were implanted.Patient had follow-up appointments and was told to give it time.Nothing has improved since the lenses were implanted.There has not been any additional surgical or medical intervention since the implants.This report will capture the lens implanted in the patient's right eye which was implanted on (b)(6) 2016.
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
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6460824
• Report Number: 9614546-2017-00273
• Device Sequence Number: 18980521
• Product Code: POE
• UDI-Device Identifier: 05050474591714
• UDI-Public: (01)05050474591714(17)210623
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 06/23/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/25/2017
• 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: Other