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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 10/28/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).Device evaluation: the product returned was received at site.The haptic detached was observed.Viscoelastic residues and particles were in lens surface.The condition is consistent with the implanted/explanted process.Due the conditions of the returned sample product deficiency could not be determined.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional investigation request were received from this production order.Conclusion: 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 Description
It was reported that a za9003 intraocular lens (iol) when being inserted into the eye was removed.It was learned however, upon further follow-up that the iol was found to have dislocated during the post-op exam.It was confirmed that how the event occurred was that the patient was implanted the lens, went out of operating room (or) but had to go back into the or during the same day, because the doctor said that the lens dislocated.Patient went back into the or for lens removal.Patient post-op was uneventful, no injuries, no adverse events.No other information was available.
 
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.
 
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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 Key9770702
MDR Text Key183677828
Report Number2648035-2020-00195
Device Sequence Number1
Product Code HQL
UDI-Device Identifier05050474528970
UDI-Public(01)05050474528970(17)231024
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
Report Date 01/01/2005,11/04/2020
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? No
Device Operator Health Professional
Device Expiration Date10/24/2023
Device Model NumberZA9003
Device Catalogue NumberZA90030180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 02/13/2020
Initial Date FDA Received02/28/2020
Supplement Dates Manufacturer Received10/25/2020
Supplement Dates FDA Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age38 YR
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