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

Model Number	ZCT150
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	09/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, remains implanted in the eye.It was indicated that the device is not returning 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.(b)(4).All pertinent information available to johnson and johnson vision has been submitted.
Event or Problem Description
It was reported that the tecnis toric intraocular lens (model zct150, +23.5 diopter) rotated after it was implanted in patient¿s left eye.The degree of rotation was not provided.It was learnt that during the post op visit, day seven (7), patient was experiencing blurry vision.Patient further stated she had blurry vision since the surgery.One day post op, (b)(6) 2018, the uncorrected visual acuity was 20/30-1, pinhole was 20/20-2.Additional information was received, where it was reported that the doctor reset (rotated) the lens corresponding to a refraction with an axis of 131 degrees.The date of lens rotation was not provided; however, was stated as planned/schedule the week of (b)(6) 2018.Patient was prescribed lotemax 0.5% and azopt 1%, with continued use of lumigan and combigan at post op visit, (b)(6) 2018.Uncorrected visual acuity 20/40-2.Best correction final visual acuity as 20/20-2.Doctor noted patient's iop (intraocular pressure) was up in both eyes and patient is a steroid responder.No further information was provided.
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.; santa ana CA
• MDR Report Key: 7941689
• Report Number: 9614546-2018-00947
• Device Sequence Number: 11104779
• Product Code: HQL
• UDI-Device Identifier: 05050474552210
• UDI-Public: (01)05050474552210(17)220202
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2022
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U235
• 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: 09/07/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 10/07/2018
• 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: Required Intervention
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005