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

Model Number	ZCT400
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date not provided, best estimate is between 4/8/2019 - 4/24/2019.If explanted; give date: not applicable as the iol remain implanted in the patient's eye.The device was not returned for analysis as the lens remains implanted in the patient¿s ocular sinister (left eye); 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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported intraocular lens (iol) model zct400 22.5 diopter lens was implanted in the patient¿s ocular sinister (left eye) on (b)(6) 2019.Iol will be explanted on (b)(6) 2019 due to complaint of lens shifted off axis.Through follow up, customer account provided additional information confirming the doctor was able to rotate the lens back into position, and the lens was not explanted/exchanged.No additional information was provided to johnson & johnson surgical vision.
Additional Manufacturer Narrative
Additional information through follow up, customer account provided additional information confirming the iol rotated 45 degrees, patient visual acuity issues due to salzman corneal nodules.There was no incision enlargement, no serious patient injury, no sutures, and no vitrectomy.No additional information was provided to johnson & johnson surgical vision.The following sections have been updated accordingly: 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 nr-0148919 and capa: 010215.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8630521
• Report Number: 3011852734-2019-00111
• Device Sequence Number: 2005135
• Product Code: HQL
• UDI-Device Identifier: 05050474553965
• UDI-Public: (01)05050474553965(17)210615
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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: 06/15/2021
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U225
• 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: 04/24/2019
• Supplement Date Received by Manufacturer: 05/24/2019; 10/25/2020
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/07/2019; 11/12/2020
• 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: 71 YR
• Date Report Sent to FDA: 01/01/2005