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 Code	No Code Available (3191)
Date of Event	06/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sex/gender: unknown, not provided.(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that a tecnis symfony, model zxr00 (16.0 diopter) was explanted from a patient's right eye (od) due to mechanical complication defined as intolerance, where the patient was unable to adapt to the lens.The lens was replaced with another lens, model zcboo (16.0 diopter).Additionally it was indicated that there was nothing wrong with the lens.The patient could not adapt to the lens and has an epiretinal membrane with a macular pucker following cataract surgery that could not be seen before cataract surgery.It was confirmed that no incision enlargement or suture was required and no vitrectomy was performed.There was no patient post-op injury reported.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the product testing was not performed as the complaint device was not returned for analysis.The reported complaint cannot be confirmed.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints revealed no similar complaints were received for this production order number to date.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: 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: 6723482
• Report Number: 9614546-2017-00632
• Device Sequence Number: 1601948
• Product Code: POE
• UDI-Device Identifier: 05050474579019
• UDI-Public: (01)05050474579019(17)210916
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/09/2018

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: 09/16/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 01/09/2018
• 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: 75 YR