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

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.

• 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: 9578807
• MDR Text Key: 177572840
• Report Number: 2648035-2020-00044
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• 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 Date: 09/11/2020
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CE08147
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/14/2020; 02/28/2020; 10/25/2020
• Supplement Dates FDA Received: 02/05/2020; 03/27/2020; 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: Z9002 20.0 DIOPTER IOL SN: (B)(4)