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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/02/2016
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 zxt225 17.0 diopter intraocular (iol) was explanted from a female patient's right eye due to dissatisfaction with the surgery outcome.There was no incision enlargement, no vitrectomy, no sutures required.There was no patient post-op injury.The lens was replaced with a zxt225 18.0 diopter iol.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation.The customer's reported event could not be confirmed.Manufacturing records were reviewed and the lens was manufactured according to specification.A search of complaints related to production order was performed.The search revealed that no similar complaints were received for this production order number.Based on the investigation results there is no indication of a product quality deficiency.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: 6134111
• Report Number: 9614546-2016-00642
• Device Sequence Number: 224110
• Product Code: POE
• UDI-Device Identifier: 05050474605732
• UDI-Public: (01)05050474605732(17)210723
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2016

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: 07/23/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2016
• Supplement Report FDA Received Date: 12/22/2016
• 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: 75 YR