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	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.If explanted, give date: not applicable, as the lens remains implanted.(b)(4).It was indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record, labeling, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens was implanted in the patient's right eye (od) (non-dominant eye) on (b)(6) 2018.Post-operatively, the patient complained of having no clear vision at any distance, seeing multiple images at all distances, and extreme halos and starbursts at night.The patient also complained of seeing at least 3 images when looking at a main object (ghost images) at 7 and 2 o'clock and at distances and that it's just a blur over 60 feet.The patient also sees concentric rings when looking at lights at night.The patient has tried covering his dominate eye with a patch to see if brain would adapt, but has not been successful.Reportedly, it's been 10 months post-operatively with no improvement.Also, the patient has had a yttrium-aluminum garnet (yag) performed, but with no improvement.The patient has also stated that the one good part about the lens implanted is that the colors are nice.The patient has tried a contact lens and taking refresh optive advanced eye drops 3-4 times per day.Also, the patient saw a specialist who stated the surgery looked well and the lens is positioned carefully.No additional information was provided.
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.; santa ana CA
• MDR Report Key: 8158444
• Report Number: 9614546-2018-01165
• Device Sequence Number: 11155410
• Product Code: MFK
• UDI-Device Identifier: 05050474605817
• UDI-Public: (01)05050474605817(17)220817
• Combination Product (Y/N): Y
• 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): 11/05/2020
• 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: 08/17/2022
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U210
• 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: 11/15/2018
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 12/12/2018
• 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: 67 YR
• Date Report Sent to FDA: 01/01/2005