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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
Date of Event	11/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the intraocular lens was not returned therefore, a product investigation could not be performed.The customer's reported event could not be confirmed.Manufacturing record review: the manufacturing records were reviewed.The product was manufactured according to specification.A search on complaints revealed that no other complaints for this order number were received to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the lens.Some visual effects may be expected due to lens design that delivers elongation of focus.These may include a perception of halos, glare, or starbursts around lights under nighttime conditions.The experience of these phenomena will be bothersome or very bothersome in some people, particularly in low-illumination conditions.On rare occasions, these visual effects may be significant enough that the patient may request removal of the iol.Based on the results of the investigation, no product deficiency was identified.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from the patient's right eye due to glare and rings around lights, dysphotopsia.Patient's vision was great, 20/20 without correction distance and j3 near.The lens was replaced with a non amo lens.No further information was provided.
Additional Manufacturer Narrative
Additional information: information was received that the patient is doing a lot better and visual acuity is now 20/30.It was also confirmed that there was no incision enlargement and no vitrectomy required.All pertinent information available to abbott medical optics 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: 6130957
• Report Number: 9614546-2016-00637
• Device Sequence Number: 10852068
• Product Code: POE
• UDI-Device Identifier: 05050474605756
• UDI-Public: (01)05050474605756(17)210716
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2017

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: 07/16/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2016
• Supplement Report FDA Received Date: 01/03/2017
• 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