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

Model Number	ZCT400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient had residual astigmatism after the implantation of lens model, zct400 toric iol (intraocular lens).As a result, lens was explanted and replaced with lens model, zct300.No complications were reported to date.No additional information provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 3/11/2019.Device returned to manufacturer: yes.Device evaluation: the product was received within a biohazard sealable ziplock bag at the manufacturing site for evaluation.The returned product was visually inspected with the unaided eye revealing the lens to be in two pieces, possibly due to explant.Further evaluation not possible.The complaint event cannot be confirmed.Manufacturing records review: the manufacturing records for the product was reviewed.No non-conformance reports, discrepancies or deviations for similar issues were found during the manufacturing record review.The product was manufactured and released according to specifications.A search in complaints history revealed that no additional complaints were received related to this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.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: 8446501
• Report Number: 3011852734-2019-00067
• Device Sequence Number: 18901509
• Product Code: HQL
• UDI-Device Identifier: 05050474554009
• UDI-Public: (01)05050474554009(17)210807
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• 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: 08/07/2021
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/16/2019; 10/25/2020
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/13/2019; 11/11/2020
• 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: 69 YR
• Date Report Sent to FDA: 01/01/2005