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

Model Number	ZXR00
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	03/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The patient reported that he had symfony intraocular lenses (iols) implanted in both his eyes.A model zxr00, 19.0 diopter lens was inserted in the patient¿s left eye.The patient reported that he can see far but not near.He cannot see 12 inches in front of him.He had a yag (yttrium aluminum garnet) done, but it did not help much.Thru follow-up with the patient, it was learned that he is experiencing halos, starbursts, and has difficulty driving at night.This has been happening since his surgery.The patient often goes fishing, but this task is difficult as the iols do not allow you to see near enough to work with the fish hook.Patient stated that he does not think there is anything wrong with the iols, and explained that he was not well-informed before the surgery.No further information was provided.Patient has bilateral lens implants.This report will capture the patient¿s left eye.A separate report is being filed for the right eye.
Additional Manufacturer Narrative
Device evaluation: the product testing could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.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.
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
• 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: 9164972
• Report Number: 9614546-2019-00951
• Device Sequence Number: 17054604
• Product Code: POE
• UDI-Device Identifier: 05050474579071
• UDI-Public: (01)05050474579071(17)221117
• 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,Followup
• Report Date (Section B): 11/09/2020
• 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: 11/17/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0190
• 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: 09/12/2019
• Supplement Date Received by Manufacturer: 10/10/2019; 10/25/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 11/06/2019; 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: Other
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005