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

Model Number	ZCT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the lens remains implanted.The device is not returning for evaluation as to date it remains implanted; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record 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 by the patient that a zct300 intraocular lens was implanted in the right eye.The patient reported ghosting and blurred vision in the right eye.The patients vision was crisp for approximately 1 1/2 days following surgery at which time the vision became blurry.The lens was checked for possible rotation but it was determined that the iol had not rotated and that it was placed as per manifest calculations.Additional information received revealed there is no planned intervention at this time.The patients symptoms affect her ability to perform daily activities.No additional information was performed.
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
• 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: 8949853
• Report Number: 9614546-2019-00789
• Device Sequence Number: 2471620
• Product Code: HQL
• UDI-Device Identifier: 05050474553422
• UDI-Public: (01)05050474553422(17)220201
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U250
• 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: 08/08/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 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: Other
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005