MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION TECNIS SYMFONY TORIC; MULTIFOCAL IOLS

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/28/2018
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 zxt225 23.0 diopter intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye) on (b)(6) 2018 and explanted on (b)(6) 2018 due to patient complaint of unknown/unspecified visual issues.Through follow up, customer account provided additional information confirming no incision enlargement, no serious patient injury, no suture(s), no vitrectomy, and the replacement lens was a zxr00 22.0 diopter iol.Patient outcome was reported 20/30 visual acuity.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Product testing could not be performed because the product was not returned.The customer's reported event could not be confirmed.During the manufacturing record review of the production order for this serial number, no product deficiency was identified.The documentation shows that the production order was manufactured according to specifications.A search of complaints revealed no similar complaints were received for this production order number.As a result of the investigation there is no indication of a product malfunction or 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 nr-0148919 and capa-010215.

• Brand Name: TECNIS SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 8057310
• Report Number: 9614546-2018-01065
• Device Sequence Number: 1921028
• Product Code: POE
• UDI-Device Identifier: 05050474605855
• UDI-Public: (01)05050474605855(17)230420
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2020
• 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: 04/20/2023
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018; 10/25/2020
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 12/12/2018; 11/04/2020
• 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: 73 YR
• Date Report Sent to FDA: 01/01/2005