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	03/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a patient underwent a bilateral symfony lens implants.After implantation of a zxr00 28.5 diopter intraocular lens (iol) on a male patient's right eye, it resulted in an hyperopic outcome.The lens was replaced with a smaller diopter, same lens model.There was no vitrectomy or incision enlargement required.The device was discard and will not be available for evaluation.Visual acuity after initial implant: refraction +1.5-.75x 135, best corrected 20/30, ucdva (uncorrected distance visual acuity) 20/50, ucdva j10.Visual acuity 10 days post-op after lens exchange: 20/25 ucdva, ucnva (uncorrected near visual acuity) 20/20, ar -.25 -.50 @87, refraction plano 20/25.Patient additionally had a symfony lens implanted in their left eye.There are no reported issues with this eye.No further information was provided.
Additional Manufacturer Narrative
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
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6459162
• Report Number: 9614546-2017-00270
• Device Sequence Number: 462170
• Product Code: POE
• UDI-Device Identifier: 05050474591769
• UDI-Public: (01)05050474591769(17)210617
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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: 06/17/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 06/07/2017
• 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: 63 YR