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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 (4010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2020
Event Type  Malfunction  
Manufacturer Narrative

Implant date: not applicable as this is not an implantable device. Explant date: not applicable as this is not an implantable device. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.

 
Event Description

It was reported that when inserting the intraocular lens (iol) into the patients left eye, the injector overrode the lens. The doctor stopped trying to inject the iol and found it was torn. The iol was partially inserted in the eye and then removed. The procedure was completed with another iol of the same model and diopter. There was no patient injury and the patient was doing fine post-surgery. Additional information received reported that the surgeon felt resistance and iol would not come out of injector. No additional information was received. This mdr captures the reported event of iol partially delivered. The reported lens damage is being reported as a vmsr.

 
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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 Key9697130
MDR Text Key178967046
Report Number2648035-2020-00126
Device Sequence Number1
Product Code KYB
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK961242
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 01/01/2005,03/10/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/11/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPSCST30
Device Catalogue NumberPSCST30
Was Device Available For Evaluation? No
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 Received02/20/2020
Is this a Reprocessed and Reused Single-Use Device? No

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