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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS SYMFONY TORIC MULTIFOCAL IOLS Back to Search Results
Model Number ZXT300
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Manufacturer Narrative

Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2018. (b)(4). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that a zxt300 intraocular lens (iol) was implanted into the patients right eye. The iol was explanted as the patient needed a different toric power, and replaced with a non-johnson and johnson iol. The patient went from a multifocal, toric iol to a non-multifocal iol. There was no additional intervention performed and the patient is doing fine post-operatively. No additional information was provided.

 
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Brand NameTECNIS SYMFONY TORIC
Type of DeviceMULTIFOCAL IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
Manufacturer (Section G)
JOHNSON & JOHNSON SURGICAL VISION, INC.
van swietenlaan 5
groningen 9728 NX
NL  9728 NX
Manufacturer Contact
somyata nagpal
1700 east st. andrew place
santa ana , CA 92705
7142478200
MDR Report Key8849213
Report Number9614546-2019-00679
Device Sequence Number1
Product CodePOE
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,08/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/31/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberZXT300
Device Catalogue NumberZXT300U200
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/30/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received08/02/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/15/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/31/2019 Patient Sequence Number: 1
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