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

Model Number	ZXT300
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a multifocal toric intraocular lens (model zxt300, +20.0 diopter) was explanted from the left eye of a female patient.The reason for the explant was not provided.Another toric lens was implanted as a replacement, model and diopter unknown.No further information was provided.
Additional Manufacturer Narrative
Device available for evaluation?: yes, returned to manufacturer on 09/13/2017.Device returned to manufacturer?: yes.The product was returned to the manufacturing site for evaluation.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.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.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 info: additional information was received and it was learnt that the intraocular lens (iol) was explanted because it was dislocated.There was no incision enlargement to remove the lens, no vitrectomy was performed and no complications were reported.Reportedly, a non-j&j lens was implanted as a replacement.The patient outcome was reported as good.No further information was provided.Based on the additional information received the following fields have been updated accordingly: all pertinent information available to johnson and 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: 6870796
• Report Number: 9614546-2017-00882
• Device Sequence Number: 1408370
• Product Code: POE
• UDI-Device Identifier: 05050474606388
• UDI-Public: (01)05050474606388(17)220411
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/05/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/11/2022
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 10/13/2017; 03/07/2018
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 11/09/2017; 04/05/2018
• 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
• Patient Age: 63 YR