MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. 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); Visual Disturbances (2140); Halo (2227)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If explanted, give date: an explant was scheduled for (b)(6) 2018, however not yet confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis symfony multifocal intraocular lens (model zxr00, +24.0 diopter) was implanted in patient's operative eye on (b)(6) 2017.It was later scheduled to be explanted on (b)(6) 2018 in a secondary procedure because of patient experiencing blurry vision, halos, visual disturbance and light sensitivity.Reportedly the near vision was 20/25.No further information was provided.
Additional Manufacturer Narrative
During follow up, it was determined that the patient's date of birth is as follows: date of birth: (b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.There was no discrepancy found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.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): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7364375
• Report Number: 9614546-2018-00278
• Device Sequence Number: 10806425
• Product Code: POE
• UDI-Device Identifier: 05050474579170
• UDI-Public: (01)05050474579170(17)211110
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2018
• Report Date (Section F): 01/01/2005

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: 11/10/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0240
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 03/23/2018; 08/16/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/22/2018; 09/10/2018
• 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: 51 YR
• Date Report Sent to FDA: 01/01/2005