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

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
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 zxt300 symfony intraocular lens (iol) exchange maybe required due to unexpected post op results.Patient's post op results: uncorrected distance visual acuity (ucdva) 20/70; uncorrected near visual acuity (ucnva) j7; spherical equivalent (se) -.375; targeted -.33.No further information was provided.
Additional Manufacturer Narrative
Additional information was received and it was learned that the lens was explanted on (b)(6) 2017 from a female patient and replaced with a pcb00 intraocular lens (iol).There was no incision enlargement or patient injury reported.Age/date of birth: (b)(6) 1947.Gender/sex: female.If explanted, give date: (b)(6) 2017.All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer 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: 6291483
• Report Number: 9614546-2017-00059
• Device Sequence Number: 16535094
• Product Code: POE
• UDI-Device Identifier: 05050474606494
• UDI-Public: (01)05050474606494(17)210628
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2017

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: 06/28/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U255
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided; 07/04/2017
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 03/01/2017; 07/27/2017
• 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: Other