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 Code	No Code Available (3191)
Date of Event	08/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2018 and (b)(6) 2018.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxr00 15.0 diopter lens was implanted in the patient's operative eye on (b)(6) 2018.It was later explanted on (b)(6) 2018 for unknown reasons.There was no incision enlargement, no vitrectomy, and no sutures used.The replacement lens was a zkb00 15.0 lens and the patient is doing good.No additional information was provided.
Additional Manufacturer Narrative
The implant date and explant date were both incorrectly reported in the initial mdr in section as (b)(6) 2018 for the implant date and (b)(6) 2018 for the explant date.The correct implant date is (b)(6) 2018 and the correct explant date is (b)(6) 2018.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
The implant date and explant date were both incorrectly reported in the initial mdr in section as (b)(6) 2018 for the implant date and (b)(6) 2018 for the explant date.The correct implant date is (b)(6) 2018 and the correct explant date is (b)(6) 2018.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 09/26/2018.Device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed viscoelastic residue and particles on the lens.No damage or scratches were observed in the lens optic zone.The customer's reported complaint was not verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the labeling review was not performed because limited information was received.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.
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 (b)(4) and capa-010215.

• Brand Name: TECNIS SYMFONY
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7833801
• Report Number: 9614546-2018-00843
• Device Sequence Number: 16639397
• Product Code: POE
• UDI-Device Identifier: 05050474591745
• UDI-Public: (01)05050474591745(17)220807
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/03/2020
• 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: 08/07/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 10/16/2018; 11/06/2018; 10/25/2020
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/23/2018; 11/09/2018; 11/03/2020
• 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
• Date Report Sent to FDA: 01/01/2005