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	09/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the intraocular lens (iol) was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Historical data analysis: a search revealed that no similar complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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.
Event or Problem Description
It was reported that a zxr00 24.0 intraocular lens (iol) was implanted on (b)(6) 2017 into the patient's right eye.The iol was explanted on (b)(6) 2019 due to intolerable glare which were first reported on (b)(6) 2017.It was also reported there was no significant residual refractive error; no dry eye.The iol exchange was performed without complication and there was no additional intervention required.The patient was stable when discharged.The account commented that the explanted lens was discarded by the surgery centre.No additional information was provided.
Additional Manufacturer Narrative
At the time of the initial report the product was reported as discarded by the customer, however the device was returned and evaluated.Therefore, the following fields have been updated accordingly.Device available for evaluation: yes.Returned to manufacturer on: 2/14/2019.Device returned to manufacturer: yes.Device evaluation: the intraocular lens (iol) was returned to the manufacturing site for evaluation.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.No other anomalies were found.The complaint cannot be confirmed.
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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8300801
• Report Number: 9614546-2019-00088
• Device Sequence Number: 10776584
• Product Code: POE
• UDI-Device Identifier: 05050474579170
• UDI-Public: (01)05050474579170(17)211118
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020
• 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: 11/18/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 02/22/2019; 10/25/2020
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 02/28/2019; 11/10/2020
• 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: 58 YR
• Date Report Sent to FDA: 01/01/2005