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); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown/not provided.The exact date of onset of symptoms or discovery was not provided (2017).If implanted; give date: unknown/not provided.(b)(4).An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a tecnis toric intraocular lens (iol), model zct150 (25.5 diopter) was explanted from a female patient's right eye (od) due to visual disturbance which significantly interfered with patient's daily life activities.A replacement lens of the same model, but different diopter (25.0) was used.There was no incision enlargement and it was indicated that the patient has recovered.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product was not returned to the manufacturer for investigation.Therefore, the customer's reported event could not be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were 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 abbott medical optics has been submitted.
Additional Manufacturer Narrative
Additional information was received and indicated that the suspect lens is a zxt150 model, serial number (b)(4).It was confirmed that the replacement lens was a zct150 model (25.0 diopter).The account stated that it is unknown if there was incision enlargement, vitrectomy or sutures done.If implanted, give date: (b)(6) 2017.Corrected data: as a result of the additional information received the following fields have been updated from what was reported in the initial mdr: brand name: tecnis symfony toric.Product code: poe.Common device name: multifocal iols.Model #: zxt150 , catalog #: zxt150u270, serial #: (b)(4), expiration date: 8/9/2021, unique identifier (udi#): (b)(4).Device manufacture date: 8/9/2016.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: 6854337
• Report Number: 9614546-2017-00863
• Device Sequence Number: 944612
• Product Code: POE
• UDI-Device Identifier: 05050474552258
• UDI-Public: (01)05050474552258(17)210220
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2017

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: 08/09/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U270
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 10/02/2017; 11/08/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 10/26/2017; 12/07/2017
• 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