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	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between (b)(6 2017 and (b)(6 2019.If explanted, give date: not applicable, as lens remains implanted.(b)(4).Device evaluation: product testing could not be performed because the product remains implanted.Complaint report cannot be verified.Manufacturing record review: the manufacturing process record was evaluated and the product was manufactured and released according to specifications.A search revealed that no similar complaints were received from this production order.Labeling review: the labeling review was completed.The directions for use (dfu) adequately provide instructions, precautions, along with warnings for the proper use and handling of the product.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient is complaining of starbursts, rings around light, ghosts in her eye, wedges- as if the lens was too small, as well as a blur.She never wore reading glasses, now she needs them.Her eyes are worse now than prior to surgery, she was promised she would get 20/30 in her right eye.She was able to read prescription bottles and now she can't.It¿s been 3 years since her surgery, she has been through multiple eye tests.She is not very happy.Follow-up with the implanting doctor was conducted.The patient¿s pre-op best corrected visual acuity (bcva) was 20/50 right eye (od) and 20/25- left eye (os) with glare.Her post op bcva was 20/25 both eye (ou).The doctor stated that despite explaining all of the risks (including the glare and haloes that the patient is experiencing) and benefits of multifocal lens implants preoperatively, the patient states that they were never explained to her.The doctor offered her iol exchange, but she has refused.The doctor also offered her a second opinion, which she has refused.No other information was provided.This mdr report pertains to the right eye (od).A separate report will be submitted for the left eye (os).
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: 8572035
• Report Number: 9614546-2019-00397
• Device Sequence Number: 10828924
• Product Code: POE
• UDI-Device Identifier: 05050474605251
• UDI-Public: (01)05050474605251(17)211213
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 12/13/2021
• 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: 04/03/2019
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 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: Other
• Date Report Sent to FDA: 01/01/2005