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 Codes	Visual Impairment (2138); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is during (b)(6) 2019.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that tecnis toric intraocular lens was explanted from patient¿s left eye due to the patient experiencing poor visual acuity.There was no incision enlargement, and no vitrectomy required.A new lens was implanted.Patient reported to be doing fine post exchange.No further information provided.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that the incorrect date of implant and incorrect affected eye were inadvertently entered in the initial emdr report; therefore, those information have been corrected in this supplemental report.The following fields were updated accordingly: event: the affected eye was the right eye (od).Implant date: (b)(6) 2018 all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device available for evaluation: yes.Returned to manufacturer on: 4/30/2019.Device returned to manufacturer: yes.Device evaluation: the product was received in a lens case for evaluation.Visual inspection with the unaided eye shows the product is cut in pieces, most probably to make explant possible.Considering the condition of the lens additional analysis is not possible.The complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.Labeling review: the labeling review was completed and revealed that the directions for use (dfu) provide the customer with proper usage instructions and guidelines.Conclusion: as a result of the investigation there is no indication of 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: 8537551
• Report Number: 9614546-2019-00361
• Device Sequence Number: 18932466
• Product Code: HQL
• UDI-Device Identifier: 05050474552555
• UDI-Public: (01)05050474552555(17)210225
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/11/2020
• 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: 02/25/2021
• Device Model Number: ZCT225
• Device Catalogue Number: ZCT225U110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 04/30/2019; 06/04/2019; 10/25/2020
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/28/2019; 06/28/2019; 11/12/2020
• 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