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

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Date of Event	02/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable as lens remains implanted.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a female patient could not tolerate the starbursts after a model zxt300 18.5 diopter intraocular lens (iol) was implanted.They tried neuroadaptation and distance spectacles.Additionally, the physician noted that the lens was anatomically perfect, but the patient was just very unhappy, and was unable to drive safely at night.There was no patient anatomy issue or a product quality issue.Patient was complaining and wanted a monofocal toric lens to reduce her unwanted images at night.No further information was provided.
Additional Manufacturer Narrative
Additional information was received and indicated that the eye affected was the right eye (od).The prior lens was bisected/discarded and a replacement lens model zct150 (18.5 diopter) lens was used.There is no defect in the lens, just rings that caused intolerable starbursts and halos.The patient reported starbursts issue on (b)(6) 2017.It was confirmed that no incision enlargement was required and no vitrectomy was performed.In addition implant and explant dates were provided and also the date when patient symptoms started.Corrected data: as a result of the additional information received the following fields have been updated from what was reported in the initial mdr: in the initial report only serious injury was indicated however with the provided explant date this field has been updated to include required intervention in the initial report the ''date of event'' of (b)(6) 2016 was listed which is also the implant date of the lens.Additional information indicated that the date of event, when patient's symptoms started was (b)(6) 2017.Date of event: (b)(6) 2017.If implanted; give date: (b)(6) 2016.If explanted; give date: (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed because the product was not returned for evaluation.Device inspection could not be performed, therefore the reported complaint could not be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints revealed no similar complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: 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: 6390185
• Report Number: 9614546-2017-00180
• Device Sequence Number: 540679
• Product Code: POE
• UDI-Device Identifier: 05050474606357
• UDI-Public: (01)05050474606357(17)210719
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2017

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: 07/19/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 04/20/2017; 05/30/2017
• 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; Required Intervention