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); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, information not provided but, the best estimate date is (b)(6) 2017.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxr00 15.5 diopter intraocular lens (iol) was implanted into the left eye (os) of the patient on (b)(6) 2017.It was later explanted on (b)(6) 2017 due to patient complaining of night time visual disturbance.The patient described vision as looking through vaseline.At explant there was no incision enlargement, vitrectomy, or sutures required.The lens was replaced with a zcboo iol of the same diopter.Reportedly, there was no patient injury and the patient is doing well with no post-operatively complication.
Additional Manufacturer Narrative
Device evaluation: the product testing was not performed as the complaint device was not returned for evaluation.The reported complaint cannot be verified.Manufacturing record review: manufacturing records were reviewed and the device was manufactured according to specification.A search on complaints history 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 johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7153736
• Report Number: 9614546-2017-01276
• Device Sequence Number: 19320659
• Product Code: POE
• UDI-Device Identifier: 05050474591752
• UDI-Public: (01)05050474591752(17)210918
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/27/2018

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: No Information
• Device Expiration Date: 09/18/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0155
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 04/27/2018
• 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