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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS Back to Search Results
Model Number ZCT300
Device Problem Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/24/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2019.If explanted, give date: not applicable, as lens remains implanted.The device is not returning for evaluation as to date it remains implanted; therefore a failure analysis of the complaint device cannot be completed.A review of the device/lot history record 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 Description
It was reported that the zct300 intraocular lens (iol) was implanted into the patients right eye as the replacement lens during an iol explant procedure.There were no complication at the time of surgery but the iol was found to have rotated 90 degrees (to 180º instead of 90º).A repositioning of the iol has been scheduled.No additional information was received.This report captures the reported event with the iol reported as having rotated.The explanted lens event is being reported in a separate mdr.
 
Manufacturer Narrative
Corrected data: upon review of the folder, it was discovered that the address of the reporter provided in the initial mdr was incorrect reported.As a result, the following fields have been updated.Section e1: facility name - (b)(6) hospital.Section e1: address line 1 - (b)(6).Section e1: city - (b)(6).Section e1: state - (b)(6).Section e1: postal code - (b)(6).Section e1: phone - (b)(6).Additional information: through follow-up additional information was provided: rotation was first observed the day after surgery - (b)(6) 2019.The repositioning was conducted on (b)(6) 2019.There were no other medical or surgical intervention required, and the patient is doing fine.The following field is now populated: section b3: date of event - (b)(6) 2019.Device evaluation: the product was not returned to the manufacturing site.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 other complaints have been received for this production order number.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.
 
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.
 
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Brand Name
TECNIS
Type of Device
TORIC IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e st andrew place
santa ana CA 92705
MDR Report Key9604685
MDR Text Key179625126
Report Number9614546-2020-00027
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474553224
UDI-Public(01)05050474553224(17)200308
Combination Product (y/n)Y
PMA/PMN Number
P980040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/08/2020
Device Model NumberZCT300
Device Catalogue NumberZCT300U150
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 12/26/2019
Initial Date FDA Received01/18/2020
Supplement Dates Manufacturer Received02/04/2020
10/25/2020
Supplement Dates FDA Received03/04/2020
11/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
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