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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 Failure to Eject
Event Date 12/03/2019
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. All pertinent information available to johnson and johnson surgical vision has been submitted.

 
Event Description

It was reported that the intraocular lens (iol) was stuck in the cartridge and partially delivered. The iol made contacted with the left eye. The iol was removed and replaced with a same model and diopter lens in the same procedure. No further information was available.

 
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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 Key9614469
Report Number2648035-2020-00069
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,04/01/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/22/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPSCST30
Device Catalogue NumberPSCST30
Device LOT NumberCE08147
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/21/2020
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 Received03/06/2020
Is this a Reprocessed and Reused Single-Use Device? No

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