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

Model Number	ZXT300
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: if explanted, give date: n/a not applicable, the lens remains implanted.The device is not returning for evaluation as it is still implanted.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, 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
Received a report from a patient indicating that after his iol implant in his right eye he experienced flashes, a grey film and the iol moved, ¿giggling¿ in eye.Per his doctor the iol moved due to his eye is larger than usual.Per the patient, the doctor said he will need to add ¿spacers¿ to hold the iol in place.The patient expected to be able to see distance and not have to wear glasses.However, he cannot see distance and is wearing glasses.He used to be able to see 10 ahead of him after his surgery.He was prescribed prednisone and diclofenac ophthalmic solution drops 3 days before surgery and continued to take them after the surgery.He applied this 4 x day the first week, 3x day the second week, and 2 x day the next 2 weeks.He is considering doing his other eye.Thru follow-up the customer confirmed that he can drive during the day and night.And has good intermediate vision.However near and distance is bad.He is wearing glasses.The patient is presently taking prednisone and diclofenac ophthalmic solution drops.He doesn't see the grey film as much, but the flashes are still there.Per the patient, the doctor plans on going back in to add spacers and reposition the lens.The patient confirmed that at the time of this call he had not done the other eye and his vision does not seem to be improving.No further 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 (b)(4) and capa: (b)(4).

• 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: 10237882
• Report Number: 2648035-2020-00470
• Device Sequence Number: 11432770
• Product Code: POE
• UDI-Device Identifier: 05050474606289
• UDI-Public: (01)05050474606289(17)240215
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020
• 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: 02/15/2024
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U150
• 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: 06/08/2020
• Supplement Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 10/29/2020
• 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
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005