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 Codes	Blurred Vision (2137); Halo (2227); 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
The patient complained of blurry vision and severe halo/glare at night and could not tolerate the adaption period and was not happy with the outcome.No surgical issues were reported.The intraocular lens was explanted from the left eye during a secondary surgical procedure.No additional information was provided to abbott medical optics.
Additional Manufacturer Narrative
Additional information received reported that there was no incision enlargement, vitrectomy, or patient injury.No additional information was provided.Device available for evaluation? yes, returned to manufacturer on 07/20/2017.Device returned to manufacturer? yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.Visual inspection at 12x microscope magnification showed the product is damaged and no further anomalies were found.The product was most likely damaged due to the explant.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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: 6669085
• Report Number: 9614546-2017-00567
• Device Sequence Number: 1157349
• Product Code: POE
• UDI-Device Identifier: 05050474591790
• UDI-Public: (01)05050474591790(17)211027
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/20/2017

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: 10/27/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Initial Date Received by Manufacturer: 06/05/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 09/20/2017
• 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