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

Model Number	ZCT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/25/2018
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 the zct225 +21.0 diopter intraocular lens (iol) was implanted into the left eye (os) of a female patient on (b)(6) 2018.Reportedly, the patient was experiencing asthenopia and near vision problems since day one post-op.As a result, the lens was explanted on (b)(6) 2018 and a zct225 +24.0 diopter was implanted as a replacement.No incision enlargement, no vitrectomy was performed and no sutures were used.The patient fully recovered and doing better with the new lens.Visual acuity pre-initial implant: 20/40.Visual acuity post-initial implant: 20/40 +1.Visual acuity post-replacement: 20/20.No additional information was provided.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 01/21/2019.Device returned to manufacturer: yes.Device evaluation: the product was received within an opened sterile pouch.The product was visually inspected with the unaided eye showing the lens was cut in half, most probably to aid in explant.Based on the condition of the return, further analysis is not possible.The customer's reported complaint was not verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaint has been received for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.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.; santa ana CA 92705
• MDR Report Key: 8270060
• Report Number: 3011852734-2019-00021
• Device Sequence Number: 141567
• Product Code: HQL
• UDI-Device Identifier: 05050474552753
• UDI-Public: (01)05050474552753(17)210813
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 11/06/2020
• 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: 08/13/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 02/13/2019; 10/25/2020
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 03/11/2019; 11/06/2020
• 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: 62 YR
• Date Report Sent to FDA: 01/01/2005