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 Codes	Visual Disturbances (2140); Halo (2227); No Code Available (3191)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted; give date: not applicable, lens remains implanted.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specifications.A search in complaint system revealed 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 and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
In a clinical research study case, at 1-month post-operative visit, the subject reported of being very bothered by halos and starbursts and having a lot of difficulty with night driving.The best-corrected visual acuity (bcva) for both eyes were reported to be 20/20.It was indicated that the procedure was completed successfully.There were no patient complication and/or related injury reported.On (b)(6) 2020, the patient returned for the 6-month postop visit and reported of being very bothered by halos and starbursts.The patient indicated they do not like to drive at night with the halos so bright, that it is hard to tell exactly what traffic is coming or where it is coming from and that the bright rays make it difficult to drive safely in night traffic.The surgeon determined that the visual symptoms are related to refractive error and not the pre-surgery issues.The lens remains implanted in the patient's eye with no intervention planned.No additional information was provided.Pre-op visual acuity: uncorrected distance visual acuity (ucdva): 20/70 right eye (od), 20/70 left eye(os).Best corrective visual acuity (bcva): 20/25 right eye (od), 20/20 left eye(os).6-month visual acuity: uncorrected distance visual acuity (ucdva): 20/20 right eye (od), 20/25 left eye(os).Best corrective visual acuity (bcva): 20/20 right eye (od), 20/20 left eye (os).The patient had bilateral lenses implanted.This report is for the patient's left eye (os).A separate report will be filed for the patient's right eye (od).
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: 10212279
• Report Number: 9614546-2020-00239
• Device Sequence Number: 14021495
• Product Code: POE
• UDI-Device Identifier: 05050474605244
• UDI-Public: (01)05050474605244(17)230127
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 01/27/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U220
• 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: 06/04/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 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: Other
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005