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 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Implant date: not applicable as this is not an implantable device.Explant date: not applicable as this is not an implantable device.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that when inserting the intraocular lens (iol) into the patients left eye, the injector overrode the lens.The doctor stopped trying to inject the iol and found it was torn.The iol was partially inserted in the eye and then removed.The procedure was completed with another iol of the same model and diopter.There was no patient injury and the patient was doing fine post-surgery.Additional information received reported that the surgeon felt resistance and iol would not come out of injector.No additional information was received.This mdr captures the reported event of iol partially delivered.The reported lens damage is being reported as a vmsr.

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: device evaluation: cartridge was not received.Only the suspect iol was returned: since cartridge was not returned, the complaint issue reported could not be verified.Product deficiency could not be determined.However, capa (b)(4).Was issued for pscst30 cartridges associated to the issue reported which would be evaluated under this complaint folder (b)(4).Production order/batch ce08147 is part of the capa (b)(4).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 that the product was manufactured and released according to specifications.A search on the catsweb system was performed and revealed nine additional investigation requests for this po number.Production order/batch ce08147 is part of the capa (b)(4).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: 9697130
• MDR Text Key: 178967046
• Report Number: 2648035-2020-00126
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)200911(10)CE08147
• 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

• Date FDA Received: 02/11/2020
• 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
• 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, SN: (B)(4)
• Patient Age: 75 YR