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

Model Number PSCST30

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information: (b)(4).Investigation were completed, and 0 investigations are pending from this period.(b)(4) no product 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 Description

This report summarizes (noe) 1 (/noe) malfunction events.The events were related to lens damage.There were no patient injuries reported associated to the events.

Manufacturer Narrative

Correction: upon further review of the unknown lots, it was determined that two unknowns belong to cartridge model pscst30.Therefore, this is to correct the initial vmsr# 2648035-2021-00023.Corrections are as follow: section b5: the correct number is 3 .Breakdown of two additional events.Lens damaged, softip problem 2 section d4: lot number of the suspect product: unknown 2.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.

• 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 Key: 11256466
• MDR Text Key: 244384870
• Report Number: 2648035-2021-00023
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)210602(10)CH08445
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Patient Sequence Number: 1