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

Model Number ZXT225

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Halo (2227); No Code Available (3191)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date not provided; however it was reported as 26 weeks post-op.(b)(6) 2018 used as an approximate date.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a female patient was implanted with a 16.5 diopter, model zxt225 intraocular lens (iol) in her right eye (od).Approximately 26 weeks postop, the patient experienced halos, a lot of glare at night, and a lack of near visual acuity.Patient's best corrected distance visual acuity (bcdva) was 20/20.On (b)(6) 2018, original lens was exchanged with 17.0 diopter, model zct225 iol and issues have been resolved with the patient's bcdva at 20/15.No additional information provided.

Manufacturer Narrative

Additional info/corrected data: additional information was received and it was learnt that the patient's visual symptoms were first reported on (b)(6) 2018.Therefore date of event was updated from (b)(6) 2018 to (b)(6) 2018.It was also reported that there was no incision enlargement, no vitrectomy was performed, no other surgical or medical intervention was required and no patient injury occurred.Reportedly, the patient is happy post-surgery.Product will not be returned as it is discarded by the surgery center.The intraocular lens (iol) is not returning for evaluation as it is discarded; 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 & johnson surgical vision, inc.Has been submitted.

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
• Type of Device: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7783495
• MDR Text Key: 117121495
• Report Number: 9614546-2018-00776
• Device Sequence Number: 1
• Product Code: POE
• UDI-Device Identifier: 05050474605725
• UDI-Public: (01)05050474605725(17)210714
• Combination Product (y/n): Y
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR