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

Model Number	ZXR00
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/30/2016
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 female patient had a latmf (left eye tecnis multifocal lens) first eye.She was very happy with her vision but wanted a bit more distance vision.The physician decided to implant a symfony in the second eye.The post-op target was plano but the outcome ended up being -1.50.The physician noted that he used the correct a-constant.The surgery resulted in an unexpected myopic outcome.The patient was not happy with the results and the physician is planning on explanting the lens and replacing it with a different power.Through follow up it was learned that the symfony lens implanted in the second eye was reportedly a +20.0 diopter.This lens was explanted and replaced with a reportedly +17.0 diopter lens.After the exchange the patient ended up with +1.50.With this result the physician is now considering explanting the 17.0 diopter lens as he may have made too much of an adjustment.Further follow up confirmed that this 17.0 diopter lens was explanted.This report will capture the symfony +17.0 diopter lens and a separate report will be filed for the +20.0 diopter lens.
Additional Manufacturer Narrative
Corrected data: additional information was provided regarding the implant and explant dates for this lens.On the initial mdr the implant date provided was (b)(6) 2016.However the correct date of implant is (b)(6) 2016.On the initial mdr the explant date provided was (b)(6) 2016.However the correct date of explant is (b)(6) 2016.Additional information: additional information was received confirming that the wrong diopter size was used and that the zxr00 17.0 diopter iol was explanted and replaced with a zkb00 19.5 diopter iol.(b)(6).All pertinent information available to abbott medical optics has been submitted.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 01/31/2017.Device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.Device inspection was performed and visual inspection with the unaided eye shows that the product is cut in half, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.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
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6239793
• Report Number: 9614546-2017-00016
• Device Sequence Number: 10973020
• Product Code: POE
• UDI-Device Identifier: 05050474579033
• UDI-Public: (01)05050474579033(17)210927
• 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 Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2017

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: 09/27/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 01/31/2017; 03/29/2017
• 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
• Patient Age: 51 YR