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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/19/2017
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 an intraocular lens (iol), model zxr00 was explanted from a patient's eye.No further information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review of the complaint file a discrepancy was found regarding the serial number ((b)(4)) which was provided in the initial mdr.This serial number ((b)(4)) was entered in error in the complaint file.The correct serial number for the suspect product involved in the reported event is (b)(4).A further review was conducted and it was discovered that medwatch report number 9614546-2017-00427 had previously been submitted for this serial number and for this same event.Therefore, no further information will be provided under this medwatch #9614546-2017-00519 as it has now been determined to be a duplicate report.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6635571
• Report Number: 9614546-2017-00519
• Device Sequence Number: 16330339
• Product Code: POE
• UDI-Device Identifier: 05050474591738
• UDI-Public: (01)05050474591738(17)211212
• 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 Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2017

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: 12/12/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0145
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 07/31/2017
• 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