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 Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017 and (b)(6) 2018.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxt150 22.5 diopter intraocular lens (iol) was implanted in the patient's right eye (od) on (b)(6) 2017.It was later explanted on (b)(6) 2018, due to the patient complaining of severe starbursts, halos and glare that interfered with night time vision.There was no incision enlargement performed, no sutures used, and no complications.The lens was replaced with a non amo lens and the patient was reported doing good post operatively.No additional information was provided.
Additional Manufacturer Narrative
The product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.The manufacturing records for the device were reviewed.The product was manufactured and released according to specification.The search in complaint history revealed 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 product.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 92705
• MDR Report Key: 7284319
• Report Number: 9614546-2018-00164
• Device Sequence Number: 13710144
• Product Code: POE
• UDI-Device Identifier: 05050474605251
• UDI-Public: (01)05050474605251(17)220607
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018
• Report Date (Section F): 01/01/2005

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: 06/07/2022
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 09/04/2018
• 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
• Date Report Sent to FDA: 01/01/2005