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); No Code Available (3191)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the product testing could not be performed as the product was not saved.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.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: 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 johnson & johnson surgical vision, inc.Has been submitted.(b)(4).
Event or Problem Description
It was reported that patient was experiencing blurry near vision during post-operative examination in her right eye (od) with implanted model zxr00 19.5 diopter iol (intraocular lens).As a result, the lens was explanted and replaced with a model zxr00 20.5 diopter lens.It was also noted that there was no additional injury to the patient.No additional information provided.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 8286374
• Report Number: 9614546-2019-00073
• Device Sequence Number: 16182808
• Product Code: POE
• UDI-Device Identifier: 05050474579088
• UDI-Public: (01)05050474579088(17)230102
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2020
• 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: Health Professional
• Device Expiration Date: 01/02/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0195
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 11/06/2020
• 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: 61 YR
• Date Report Sent to FDA: 01/01/2005