MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. TECNIS SYMFONY TORIC; TORIC IOLS

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	06/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Explant date: if explanted, give date: not applicable as the lens remains implanted and therefore not explanted.The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A female patient reported that a symfony toric intraocular lens (iol) was implanted in her right eye (od) on (b)(6) 2018.Reportedly, at the follow up visit with the surgeon on (b)(6) 2018, the patient complained that the lens was not working as she could not read anything.The patient reported being an avid reader and now she is frustrated not being able to read small or large print.Reportedly, the symptoms have affected her ability to perform daily activities.It was also reported that plugs were implanted in the patient's eye due to dry eye symptoms and to help with the patient's vision issues; but they did not help.The patient continues to experience the same visual issues.Yag (yttrium aluminum garnet) laser was also performed on (b)(6) 2018.The patient stated that her vision is blurry up-close but is happy with her distant vision.The surgeon will implant an intraocular lens (non johnson & johnson lens) in the patient left eye (os) and will then reassess the patient'' vision to determine if reading glasses will be necessary.To date there are no planned intervention for the right eye and the lens remains implanted.No additional information was provided to johnson and johnson surgical vision, inc.
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: TORIC IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7959653
• Report Number: 9614546-2018-00959
• Device Sequence Number: 201354
• Product Code: POE
• UDI-Device Identifier: 05050474605879
• UDI-Public: (01)05050474605879(17)220706
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020
• 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: 07/06/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U240
• 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: 09/13/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/03/2020
• 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: Other
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005