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

Model Number	ZCT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided but best estimate is between 1/17/2019-2/5/2019.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted due to a goal change.The explanted lens was exchanged for a diopter model but same diopter iol.Patient outcome was noted as alright.No further information was provided.
Additional Manufacturer Narrative
Additional information received reported that the patient was experiencing blurriness.The lens may not have met the astigmatism correction goal.Lens implant left eye.There was no incision enlargement, vitrectomy, or sutures.Patient is fine.No further information was provided.The following has been updated accordingly: other relevant history: astigmatism.Device available for evaluation: yes.Returned to manufacturer on: 03/14/2019.Device returned to manufacturer: yes.Device evaluation: the returned lens was received for evaluation.Product was received inside a plastic sample vial labelled with patient identifiers kept inside of a resealable plastic biohazard specimen bag.A visual inspection of the returned device showed the lens was cut in half, most probably to aid in explant.Based on the condition of the returned lens, further analysis was not possible.The complaint event cannot be confirmed.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no additional complaints were received for this production order number.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
Corrected data: in review of the file and initial mdr, an error was found in the wording of the description of the event, instead of stating; the explanted lens was exchanged for a diopter model but same diopter iol.The description should have read as the following: it was reported that the intraocular lens (iol) was explanted due to a goal change.The explanted lens was exchanged for a different model but same diopter iol.No further information was provided.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: 8458626
• Report Number: 3011852734-2019-00072
• Device Sequence Number: 13539227
• Product Code: HQL
• UDI-Device Identifier: 05050474552050
• UDI-Public: (01)05050474552050(17)210816
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 08/16/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/01/2019; 06/04/2019; 10/25/2020
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/30/2019; 06/04/2019; 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
• Date Report Sent to FDA: 01/01/2005