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

Model Number	ZXT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of onset of symptoms is unknown/not provided.Date of explant was scheduled for (b)(6) 2017 however not confirmed.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The account reported that a doctor will be performing an explant of a model zxt375 20.0 diopter intraocular lens (iol) from the right eye (od) of a male patient on (b)(6) 2017 due to patient complaints of intolerable night time dysphotopsia.The patient currently has bilateral symfony lenses and the doctor''s surgical plan is to explant only one eye at the moment and replace the lens with a toric lens, model zct450, 20.0 diopter that will be prescribed for distance.Additional information received indicated that the lens will not be returned as it was discarded post explanation.No further information was provided.
Additional Manufacturer Narrative
Additional information was received and it was learnt that the there were no complications during the lens explant and the patient is now happy.No further information was provided.In review of patient data, found that the lens was explanted on (b)(6) 2017 as initially planned.If explanted; give date: (b)(6) 2017.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Initially, it was reported that the physician planned to explant the lens.However, additional information was received confirming that the lens was already explanted due to halos.(b)(4).All pertinent information available to the manufacturer has been submitted.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 6659433
• Report Number: 9614546-2017-00556
• Device Sequence Number: 1616112
• Product Code: POE
• UDI-Device Identifier: 05050474606975
• UDI-Public: (01)05050474606975(17)210923
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 10/30/2017

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: 09/23/2021
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 06/27/2017; 08/30/2017; 10/06/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 07/21/2017; 09/23/2017; 10/31/2017
• 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