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	Therapeutic Effects, Unexpected (2099); No Code Available (3191)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient¿s right eye due to off target after cataract extraction.It was learned that there was no incision enlargement, vitrectomy, or sutures required.No patient post-op injury.The suspect iol was replaced with the same model iol but lower diopter power (23.5).No other information was provided.
Additional Manufacturer Narrative
Corrected data: in review of the file, the initial emdr was submitted; however, section h3: ¿reason for non-evaluation¿ was inadvertently not provided.This section has been updated in this supplemental mdr submission.H3: reason for non-evaluation: device evaluation anticipated, but not yet begun (02).Additional information: section d10.Device available for evaluation? yes.Returned to manufacturer on: 1/6/2021.Section h3.Device returned to manufacturer? yes.Device evaluation: the lens was received submerged in an unknown solution inside a specimen cup.The lens was cleaned and visual inspection under magnification revealed that the lens was received cut in half, which is consistent with a lens that as handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.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 other 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 11016971
• Report Number: 9614546-2020-00517
• Device Sequence Number: 14351132
• Product Code: POE
• UDI-Device Identifier: 05050474579200
• UDI-Public: (01)05050474579200(17)231001
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: 10/01/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/11/2021
• 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: 64 YR