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	Visual Impairment (2138); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date of event is unknown but best estimate is between (b)(6) 2017.If explanted; give date: not applicable; however a planned explant was reported for (b)(6) 2017.Patient code of (b)(4) is provided for planned explant of the intraocular lens.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A report was received that a tecnis symfony toric model zxt150 20.5 diopter intraocular lens (iol) was planned for explant from a patient¿s operative eye as there was dissatisfaction with the patient¿s near vision and experiencing halos.The patient was initially treated with eye drops and artificial tears but was not satisfied.The planned explant was for an exchange with a standard iol.No further information was provided.
Additional Manufacturer Narrative
Additional information received reported the patient¿s operative eye was the right eye (od).The planned explant was postponed due to the patient postponing the procedure and then cancelling the day before procedure was to take place.The physician¿s name is dr.(b)(6).Based on the additional information received the following fields have been updated accordingly: initial reporter name: dr.(b)(6).Health professional: yes occupation: physician.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturing site as it remains implanted.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 product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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 johnson & johnson surgical vision, inc.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: 7043130
• Report Number: 9614546-2017-01120
• Device Sequence Number: 2144169
• Product Code: POE
• UDI-Device Identifier: 05050474605213
• UDI-Public: (01)05050474605213(17)220420
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2018

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: 04/20/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 01/25/2018; 02/26/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 02/21/2018; 03/26/2018
• 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