MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS SYMFONY; MULTIFOCAL IOLS

Model Number	ZXR00
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between 11/08/2017 and 10/30/2018.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a zxr00 10.5 diopter lens was implanted in the patient's right eye (od) on (b)(6) 2017.It was later explanted on (b)(6) 2018 due to a mechanical failure.There was an incision enlargement made, but no vitrectomy was performed and no sutures were used.Reportedly, there was no patient injury.No additional information was provided.
Additional Manufacturer Narrative
The product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.The manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.The labeling review was not reviewed 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
Device available for evaluation: yes.Returned to manufacturer on: 11/28/2018.Device returned to manufacturer: yes.Product testing: the product was received in a zip lock bag.The product was disinfected according to procedure wv0491.The product is inspected by a qualified inspector using a microscope with a 12x magnification.It can be seen that the lens is contaminated, dust particles are present.This is expected as the lens was transported from controlled environment during manufacturing to a non-sterile, non-environmental controlled area.Investigation of the return sample and the condition of the return sample do not suggest the failure was introduced during manufacturing.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 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
• MDR Report Key: 8097815
• Report Number: 9614546-2018-01108
• Device Sequence Number: 1988043
• Product Code: POE
• UDI-Device Identifier: 05050474591653
• UDI-Public: (01)05050474591653(17)220519
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 12/06/2018; 01/30/2019; 10/25/2020
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 12/13/2018; 02/24/2019; 11/05/2020
• 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