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	Visual Disturbances (2140); No Code Available (3191)
Date of Event	10/02/2019
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 patient was experiencing positive dysphotopsia.Through follow up, it was learned that 1-day post-operative (op), the patient complained of fluttering in peripheral vision.2 weeks post-op, the patient complained of seeing flashing light.Unaided visual acuity was 20/25.The patient was sent for a second opinion and decided to proceed with an iol exchange.The iol was explanted and an incision enlargement was required, however, there were no other complications.The surgery was completed using a non-johnson & johnson replacement lens.The patient was given advil to relieve pain post-op.Unaided visual acuity was 20/200.No additional information was provided.
Additional Manufacturer Narrative
Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 12/9/19.Section h3: device returned to manufacturer: yes.Device evaluation: a visual inspection with the unaided eye revealed the lens was cut in half with traces of blood residue, most probably due to explant.Based on the condition of the lens, further analysis is not possible.The complaint event cannot be confirmed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.H3 other text : placeholder.
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: 9383839
• Report Number: 2020664-2019-00017
• Device Sequence Number: 14008019
• Product Code: HQL
• UDI-Device Identifier: 05050474552159
• UDI-Public: (01)05050474552159(17)210802
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2020
• 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: 08/02/2021
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 01/22/2020; 10/25/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/18/2020; 11/05/2020
• 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: 75 YR
• Date Report Sent to FDA: 01/01/2005