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

Model Number	PSCST30
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: breakdown of 4 events are as follows: cartridge tip cracked or damaged, 2.Cartridge tip cracked or damaged, lens damage, 2.Lot numbers of the suspect product: ce08960, 2; ce08539, 1; ce09371, 1.3 investigations were completed and 1 is pending for this time period.Breakdown of 3 completed investigations 2 cartridge tip cracked or damaged - both for lot number ce08960.1 cartridge tip cracked/damaged, haptic damaged, stuck in cartridge - for lot number ce08539.The investigation were completed.The product was returned.The investigation concluded that the product met manufacturing release criteria.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
This report summarizes 4 malfunction events.The events were related to cartridge tip cracked or damaged.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
Additional information: 1 investigation was completed.The breakdown of investigation observation are as follows for respective lot number: ce09371 - no product returned.The investigations was completed.No product was returned.The investigation concluded that the product met manufacturing release criteria.All pertinent information available to johnson & johnson surgical vision, inc.That was received during the time period that covers this voluntary malfunction summary report has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f and g.4 date 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 nr-0148919 and capa-010215.

• Brand Name: SILVER
• Common Device Name: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10310855
• Report Number: 2648035-2020-00538
• Device Sequence Number: 16344572
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034
• Combination Product (Y/N): Y
• PMA/510(K) Number: K961242
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: No Information
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/14/2005
• Supplement Date Received by Manufacturer: 01/14/2005; 10/25/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 10/31/2020; 12/04/2020
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005