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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.If explanted, give date: not applicable as the lens remains implanted.However, an explant is scheduled.(b)(4).Device evaluation: the device was not returned to the manufacturer for evaluation as it remains implanted to date.Device inspection could not be performed.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.
Event or Problem Description
Initially, it was reported a patient had issues with her vision after implantation of a zxt150 7.0 diopter intraocular lens (iol) in her left eye at axis 75 degrees.Implant took place on (b)(6) 2016.Patient claims that she could not see near her phone and (b)(6).Furthermore, she added that at night it looks like she's seeing fireworks.But her distance vision is well.The clinic confirmed that the lens implanted in the patient had no issues and surgery went well.The patient followed up with the clinic and patient is still complaining but doctor doesn't know why, as her visual acuity (va) is 20/20, uncomplicated s/p cataract and perfect distance outcome.She complains of starbursts but doctor thinks that they should go away in time.There was plan to explant.On (b)(4) 2017, amo was notified that the patient is now a candidate for a lens exchange as she is extremely unhappy with the lens.Patient is experiencing a significant amount of night time glare.Patient is scheduled to have the lens explanted.No further information was provided.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6675656
• Report Number: 9614546-2017-00576
• Device Sequence Number: 72734
• Product Code: POE
• UDI-Device Identifier: 05050474604940
• UDI-Public: (01)05050474604940(17)210708
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2017

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: 07/08/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 06/28/2017
• 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