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

Model Number	ZXT225
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Visual Disturbances (2140); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event - unknown.Account did not provide an exact date of when the visual disturbance and lens off center was observed, (2017).Explant date - account reported surgeon was planning to explant on (b)(6) 2017 and the lens was reported as explanted therefore this date has been provided.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that patient underwent an implantation of a zxt225 22.0 diopter tecnis symfony toric intraocular lens (iol) on (b)(6) 2017.The patient presented post op with the lens off center and experiencing visual disturbance.Surgeon scheduled to perform an iol explant on (b)(6) 2017.Further information was provided in follow up with the surgery center.It was learned the lens was on axis, just decentered (no rotation noted).The affected eye is the left eye.The lens was explanted and an incision enlargement and one suture were required, there was no vitrectomy performed.The replacement lens was another zct225 of a higher diopter (23.5).
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned to 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 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 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: 6542879
• Report Number: 9614546-2017-00356
• Device Sequence Number: 749459
• Product Code: POE
• UDI-Device Identifier: 05050474605831
• UDI-Public: (01)05050474605831(17)210829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 09/01/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/29/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 09/01/2017
• 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