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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 Problems Device Damaged by Another Device (2915); Failure to Eject (4010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Additional information: date of event: unknown as information was not provided.Lot number: unknown as information was not provided.Expiration date: unknown as product lot number was not provided.Udi number: a complete udi number is unknown as product lot number was not provided.If implanted, give date: not applicable, as the cartridge is not an implantable device.If explanted, give date: not applicable, as the cartridge is not an implantable device.Device manufacture date: unknown, as product lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Event Description
It was reported z9002 20.0 diopter intraocular lens (iol) became partially stuck in the pscst30 cartridge when the tip of inserter overrode the lens optic.It was reported the haptic/optic had contact with the patient¿s operative eye, there was no incision enlargement, no suture(s), no vitrectomy, and a different lens was implanted with no injury to patient.No additional information was provided to johnson & johnson surgical vision.
 
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.
 
Manufacturer Narrative
Additional information was received providing the lot number of the reported device.Therefore, the following fields have been updated accordingly; section d-4: lot number: information was updated from unknown to ce08147.Section d-4: expiration date: information was updated from unknown to 09/11/2020.Section d-4: udi number: information was updated from (b)(4).Section h-4: manufacture date: information was updated from unknown to 09/11/2019.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
Manufacturer Narrative
Additional information: section h-3: device evaluated by manufacturer: yes.Device evaluation: product testing could not be performed because the product was not returned.A product quality deficiency could not be confirmed.The reported issue was not verified.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 of complaints revealed that thirteen (13) additional investigation request (ir) for this production order number has been received.At the time of this report six investigations are ongoing.For the other investigations no product deficiency was identified.Conclusion: as a result, of the investigation the reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
 
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Brand Name
SILVER
Type of Device
SURGICAL ADJUNCTS
Manufacturer (Section D)
JOHNSON & JOHNSON SURGICAL VISION, INC.
1700 e. st. andrew place
santa ana CA 92705
MDR Report Key9578807
MDR Text Key177572840
Report Number2648035-2020-00044
Device Sequence Number1
Product Code KYB
UDI-Device Identifier05050474530034
UDI-Public(01)05050474530034(10)UNKNOWN
Combination Product (y/n)Y
PMA/PMN Number
K961242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup,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? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/11/2020
Device Model NumberPSCST30
Device Catalogue NumberPSCST30
Device Lot NumberCE08147
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 12/17/2019
Initial Date FDA Received01/10/2020
Supplement Dates Manufacturer Received01/14/2020
02/28/2020
10/25/2020
Supplement Dates FDA Received02/05/2020
03/27/2020
11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
Z9002 20.0 DIOPTER IOL SN: (B)(4)
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