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

Model Number	ZXT300
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Visual Disturbances (2140); Vitrectomy (2643); No Code Available (3191)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: exact date unknown; however, reported as (b)(6) 2019.(b)(4).Attempts have been made to obtain missing information; however, to date, no response has been received.It was indicated that the device is not available for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot 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.
Event or Problem Description
It was reported that the patient's vision became altered when the zxt300 intraocular lens (iol) became decentered and the patient wanted it removed.The patient chose to wait approximately one month before having the lens removed.The physician who performed the explant was different from the one that implanted the iol.The patient was doing fine after the explant.A vitrectomy was required; but it was unknown if an incision enlargement or sutures were required.No additional information was received.Pre-op visual acuity: 20/200.Post-op visual acuity: 20/70 without correction.
Additional Manufacturer Narrative
Additional information received reported the dislocation was first documented on (b)(6) 2019.The explant of the initial intraocular lens (iol) was performed by a different doctor than the implanting surgeon.No additional information was available regarding the explant.There were no injuries during the implant of the initial iol.As a result the following field has been updated: correction: date of event: (b)(6) 2019.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 TORIC
• 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: 8701613
• Report Number: 9614546-2019-00549
• Device Sequence Number: 1993156
• Product Code: HQL
• UDI-Device Identifier: 05050474606388
• UDI-Public: (01)05050474606388(17)210823
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2021
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U200
• 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: 05/21/2019
• Supplement Date Received by Manufacturer: 07/11/2019; 10/25/2020
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/19/2019; 11/13/2020
• 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: 68 YR
• Date Report Sent to FDA: 01/01/2005