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 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Not applicable, as the cartridge is not an implantable device.Not applicable, as the cartridge is not an implantable device.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the intraocular lens would not come out of the cartridge.Additional information received reported that the lens was partially inserted.There was no patient injury or intervention.No additional information was received.

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.

Manufacturer Narrative

Additional information: section d10: device available for evaluation? yes.Returned to manufacturer on: 2/3/2020.Section h3: device returned to manufacturer? yes.Device evaluation: the sample was returned on 02/03/2020.The sample was evaluated, and the cartridge was observed crack in the tube and tip area.Also, stress marks are observed in the tube area that could be related to the handling of the lens in a surgical procedure.No lens was received.Due to the condition in which the cartridge returned, the incoming inspection could not be done.The reported issue was not verified and due to the product returned open and handled a product quality deficiency or product malfunction could not be determined.The complaint issue could not be verified to be associated to manufacturing process.However, production order/batch lot ce07812 is part of the capa-009710 bracketing, which was initiated due to an increase in delivery issues related to using cartridge model pscst30.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.However, a complaint search revealed that 7 other complaints have been received for this production order number.Production order/batch ce07812 is part of the capa-009710 bracketing, which was initiated due to an increase in delivery issues related to using cartridge model pscst30.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be 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: 9662469
• MDR Text Key: 178574116
• Report Number: 2648035-2020-00105
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)200821(10)CE07812
• 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
• Report Date: 01/01/2005,11/03/2020

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: 08/21/2020
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CE07812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• 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: 01/08/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 03/04/2020; 10/25/2020
• Supplement Dates FDA Received: 03/04/2020; 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: Z90002 LENS SN:(B)(6)