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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age/date of birth: unknown, information not provided.Date of event: unknown, not provided.If explanted, give date: not applicable, remains implanted in the eye.(b)(4), device evaluation: product testing could not be performed because the product was not returned as it is still implanted.The reported complaint was not confirmed.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported.The search revealed that no similar complaints were received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that patient had tecnis symfony toric multifocal intraocular lens implanted in both eyes.Reportedly patient¿s vision is little out of focus with no discomfort.Patient understood that there was no guarantee of the close-up vision, however 2ft-8ft things are clear- past 15-20 ft things are out of focus.Surgeon ruled out lasik and offered to replace the lens.Patient has been using bole sunglasses that has a yellowish tint and when patient wears them the vision gets clearer- they are stock- nonprescription lenses.This report will capture information for patient¿s right eye.Another report is being submitted for patient¿s left operative eye.No further information provided.
Additional Manufacturer Narrative
Additional information: additional information was received, and it was learnt that patient has been having halos and has been using nonprescription glasses.He can read and his daily activities at day time is good however they are out of focus, the quality of vision is a problem.Per doctor on his post op examination he had 20/20 and 20/25 vision.Doctor performed yag and also recommended to replace with monofocal lens, however patient has not considered an explant.No further information provided.All pertinent information available to johnson and johnson surgical vision 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 (b)(4), 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: 8997158
• Report Number: 9614546-2019-00851
• Device Sequence Number: 3380834
• Product Code: POE
• UDI-Device Identifier: 05050474605251
• UDI-Public: (01)05050474605251(17)211205
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 12/05/2021
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U225
• 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: 08/15/2019
• Supplement Date Received by Manufacturer: 09/25/2019; 10/25/2020
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/18/2019; 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: Required Intervention
• Date Report Sent to FDA: 01/01/2005