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)
Date of Event	01/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a zxt300 29.0 diopter intraocular lens (iol) was explanted and exchanged for a lower diopter (26.5) lens of the same model.Through follow up with the surgery center it was confirmed that the postop refraction was not what was expected.The following information was provided: patient¿s measurements were: pre-op rx +4.25 -1.00 x 177, post-op -1.75 -0.50 x 60.At one (1) week post iol exchange the patient was rx -0.25 -1.00 x140 add: +2.75 near: j2@16" far: 20/30 visual acuity.The patient will continue to be followed as the patient is saying that their vision is better some but still not great.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 03/20/2017 device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.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 reported issue could not be confirmed in the returned sample.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: 6363435
• Report Number: 9614546-2017-00144
• Device Sequence Number: 744459
• Product Code: POE
• UDI-Device Identifier: 05050474606562
• UDI-Public: (01)05050474606562(17)210701
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2017

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: 07/01/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2017
• Supplement Report FDA Received Date: 05/21/2017
• 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