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	Halo (2227); No Code Available (3191)
Date of Event	05/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2017.(b)(4).An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a zxr00 12.5 diopter intraocular lens (iol) was implanted in the patient''s right eye (od) on (b)(6) 2017.It was later explanted on (b)(6) 2017 due to patient complaints about halos.The replacement lens was a z9002 12.5 diopter lens.No additional information was provided.
Additional Manufacturer Narrative
Additional information received reported the visual symptoms started 3 days post-operatively from the initial implant.The patient did not have any contributing medical history, there was no patient injury, and the patient is doing well post-operatively.There was no incision enlargement and no vitrectomy performed.There was no other medical or surgical intervention required.No additional information was provided.Date of event: (b)(6) 2017.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Date of this report: on mdr follow up #1, the date in section was inadvertently not populated.(b)(6) 2018 (b)(6) 2018) should have been entered.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 07/07/2017.Device returned to manufacturer? yes.Device evaluation: the product was received in a container with liquid.The product is inspected by a qualified inspector using a microscope with a 12x magnification and no anomalies were found.The reported complaint cannot be confirmed.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed that no similar complaints were received for this production order.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 92705
• MDR Report Key: 7272140
• Report Number: 9614546-2018-00151
• Device Sequence Number: 18867891
• Product Code: POE
• UDI-Device Identifier: 05050474591691
• UDI-Public: (01)05050474591691(17)220404
• 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,Followup,Followup
• Report Date (Section B): 06/11/2018

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: 04/04/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Initial Date Received by Manufacturer: 01/18/2018
• Supplement Date Received by Manufacturer: 02/15/2018; 03/14/2018; 05/16/2018
• Initial Report FDA Received Date: 02/14/2018
• Supplement Report FDA Received Date: 03/14/2018; 04/13/2018; 06/11/2018
• 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