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

Model Number PSCST30

Device Problem Failure to Eject (4010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number: unknown, not provided.Expiration date: unknown as there is no lot number provided.Udi number: a complete udi number is unknown as lot number of the device was not provided.Not applicable as this is not an implantable device.Not applicable as this is not an implantable device.Device manufacture date: unknown as there is no lot number provided.Device evaluation: the product was not returned to the manufacturing site.Therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing record review could not be performed because the lot number of the complaint product is unknown.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain missing information; however, additional information was provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a z9002 intraocular lens (iol) did not advance properly from the cartridge.The lens had patient contact.Attempts to obtain the product lot and serial numbers were made but the account could not provide the information.Additional information received revealed that the lenses were not inserted.No additional information was received.This report is for the first of the two reported events.

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 nr-0148919 and capa-010215.

• 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: 9588709
• MDR Text Key: 180153508
• Report Number: 2648035-2020-00054
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: UNKNOWN
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: Z9002 INTRAOCULAR LENS