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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SILVER SURGICAL ADJUNCTS

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JOHNSON & JOHNSON SURGICAL VISION, INC. SILVER SURGICAL ADJUNCTS Back to Search Results
Model Number PSCST30
Device Problem Contamination (1120)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2019
Event Type  malfunction  
Manufacturer Narrative
If implanted, give date: not applicable as this is not an implantable device.   if explanted, give date: not applicable as this is not an implantable device.   device evaluation: product testing could not be performed because the product was not returned. The reported complaint was not confirmed. Manufacturing record review: the manufacturing process record was evaluated and no deviation was found during process related to the complaint issue reported. The search revealed that two other complaints were received for this production order number. Both investigations were due to deformed tips; unrelated to this event. There were no product problems and product met manufacturing release criteria. Conclusion: as a result of the investigation, there is no indication of a product quality deficiency. All pertinent information available to johnson and johnson surgical vision has been submitted.
 
Event Description
It was reported that debris was found on haptic of intraocular lens. Lens was implanted successfully after the debris was removed from haptic. Patient was doing well. This report captures information for cartridge. Another report is being submitted for the lens. No further information provided.
 
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Brand NameSILVER
Type of DeviceSURGICAL ADJUNCTS
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.
road 402 north, km 4.2
anasco industrial park
anasco PR 00610
Manufacturer Contact
somyata nagpal
1700 east st. andrew place
santa ana, CA 92705
7142478200
MDR Report Key9043417
MDR Text Key158890183
Report Number2648035-2019-01005
Device Sequence Number1
Product Code KYB
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K961242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,11/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/25/2020
Device Model NumberPSCST30
Device Catalogue NumberPSCST30
Device Lot NumberCE03159
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received10/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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