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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; MONOFOCAL IOLS Back to Search Results
Model Number ZA9003
Device Problem Unintended Movement (3026)
Patient Problem No Code Available (3191)
Event Date 01/30/2020
Event Type  Injury  
Manufacturer Narrative
Patient gender: unknown as information was not provided.If implanted, give date: not applicable, as lens was removed/ replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/ replaced in the initial surgery.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
After za9003 20.0 diopter intraocular lens (iol) was placed in the patient¿s operative eye customer account reported the za9003 lens was removed, during the same procedure, as the eye was pushing the iol out and replaced with a non-johnson & johnson surgical vision lens.It was also reported there was no patient injury however the incision was enlarged, suture(s) were required.Patient outcome post-op was reported as good.No further information is available.No additional information was provided to johnson & johnson surgical vision.
 
Manufacturer Narrative
Device evaluation: no lens returned.Only carton box, lens case/insert, and dfu (directions for use) were returned.However, there was no failure against the lens reported.Manufacturing records review: the manufacturing records for the product were reviewed, the product was manufactured and released according to specification.Historical data analysis: a search revealed that no additional complaints for this production order number have been received.Conclusion: as a result of the investigation, there is no indication of a product malfunction or product quality deficiency.The reported issue was not 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 (b)(4) and capa(b)(4).
 
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Brand Name
TECNIS
Type of Device
MONOFOCAL IOLS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e. st. andrew place
santa ana CA 92705
MDR Report Key9748861
MDR Text Key180784821
Report Number2648035-2020-00176
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474529014
UDI-Public(01)05050474529014(17)241203
Combination Product (y/n)Y
PMA/PMN Number
P990080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,11/02/2020
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? Yes
Device Operator Health Professional
Device Model NumberZA9003
Device Catalogue NumberZA90030200
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 01/30/2020
Initial Date FDA Received02/25/2020
Supplement Dates Manufacturer Received03/16/2020
10/25/2020
Supplement Dates FDA Received04/09/2020
11/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
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