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	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2019.(b)(4).Device evaluation: product testing could not be performed because the product was not returned.The complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no similar complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient had bilateral intraocular lens implants in her eyes about 5 weeks ago.Follow-up confirmed that the lenses are a zxt150, left eye (os) and a zxr00, right eye (od).Patient stated that her vision didn't change even after >1 month implant.She needs readers to be able to go about her daily activities.Further information was received recently where it was reported that after about 4 months post-op, the intraocular lens (iol) in the patient¿s right eye was explanted.This was due to patient still being unhappy with the quality of the lens.Secondary to patient not being able to see distance, she also saw fireworks when looking at street signs, and had diplopia as well.Post op, glare is better and halos decreased.The patient is scheduled to have left iol exchange in the future.No further information was provided.
Additional Manufacturer Narrative
Correction data: upon further review, it was learned that the patient code unexpected post-op refraction is inadvertently missed.Therefore, it has been corrected in this supplemental report.(b)(4): unexpected post-op refraction.Additional information: the right iol was replaced with aab00 iol, 17.5 diopter.Device available for evaluation, returned to manufacturer on: 12/9/2019.Device evaluation: on december 9, 2019 the return sample was received.It can be seen that the lens optic is torn and there is an unspecified imprint visible on the lens, most likely to make the explant possible.No further anomalies were found.The complaint cannot be confirmed.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.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9406374
• Report Number: 9614546-2019-01077
• Device Sequence Number: 14104944
• Product Code: POE
• UDI-Device Identifier: 05050474579040
• UDI-Public: (01)05050474579040(17)211221
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 12/21/2021
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 12/19/2019; 10/25/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/02/2020; 11/12/2020
• 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