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

Model Number	ZXT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted.However, there is a planned explant schedule on (b)(6) 2019.(b)(4).Device evaluation: the product was not returned to the manufacturing site, as it remains implanted.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.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
It was reported that a zxt375 multifocal intraocular lens was implanted in the patient¿s operative eye.The patient reported post-operatively experiencing blurry vision at approximately three feet and on.Via follow-up the patient confirmed she is still experiencing blurry vision.Reportedly the doctor said her eyes are not normal and she will need a different diopter.Her explant date is scheduled for (b)(6) 2019.No additional information was provided.
Additional Manufacturer Narrative
Additional: if implanted, give date: the initial implant date provided by the patient was (b)(6) 2019.However, the account clarified to (b)(6) 2019.Explanted date: (b)(6) 2019.Received additional information from the patient.The patient called to confirm that iol model zxt375, serial#: (b)(4) in her left eye was explanted and replaced with iol model zxt300, serial number (b)(4).The doctor explained to her that she is a special case because her eyes are so small.She has had both eyes done.She will have to wear contacts.The doctor offered the possibility of laser surgery to correct her vision but the patient is not interested as she is tired of surgeries.No additional procedures had been planned or scheduled and the patient is not considering any more surgeries.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional: before she had any surgery, the doctor only tested her vision with the contacts on.Pre-surgery vision with contacts: left eye: 20/50 +2.Right eye: 20/30 -2.Post-surgery left eye: l 20/50 +2, without contacts.But her vision was blurry so the iol was explanted.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 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: 8393026
• Report Number: 9614546-2019-00190
• Device Sequence Number: 11120746
• Product Code: POE
• UDI-Device Identifier: 05050474607132
• UDI-Public: (01)05050474607132(17)221203
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 12/03/2022
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U280
• 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: 02/21/2019
• Supplement Date Received by Manufacturer: 06/25/2019; 07/11/2019; 10/25/2020
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 07/08/2019; 08/02/2019; 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: Required Intervention
• Date Report Sent to FDA: 01/01/2005