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

Model Number	ZXT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Halo (2227); No Code Available (3191)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: not applicable; to date the lens remains implanted.(b)(4).Device evaluation: product testing could not be performed because the product was not returned; it remains implanted.The consumer's reported complaint could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.The review revealed that the product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, along with warnings for the proper handling and use of the product.Historical analysis: a search revealed that no similar investigation request has been received for this production order number.Based on the results of the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Patient called to report her experience with the intraocular lens (iol) implants.Patient underwent bilateral lens implants in (b)(6) 2018.Patient reported she started to have halos/glares and circles around the lights when driving at night right after surgery.In the morning, she had to wear anti-glare sunglasses because of the glares and could not read up close.Patient was prescribed prescriptive glasses and would be picking them up the following week as her doctor said that it will help with her vision.Doctor performed a laser procedure on the right eye to remove scar tissue.The doctor informed the patient that it was too soon to determine if the customer may need a lens exchange and she was advised to wait for a year before considering lens explant(s).Patient had bilateral lens implants; this report represents the lens implanted in the right eye.A separate report will be filed for the left eye.
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 SYMFONY TORIC
• Common Device Name: MULTIFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8427535
• Report Number: 9614546-2019-00237
• Device Sequence Number: 13500896
• Product Code: POE
• UDI-Device Identifier: 05050474605848
• UDI-Public: (01)05050474605848(17)220927
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 09/27/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 11/10/2020
• 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: Other
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005