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

Model Number PSCST30

Device Problem Premature Activation (1484)

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

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information: if implanted, give date: not applicable the cartridge is not an implantable device.If explanted, give date: not applicable 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 a model z9002 iol 22.0 diopter intraocular lens (iol) suddenly came out upside down into the patient's left eye.The iol was removed.Reportedly, there was no incision enlargement.Another cartridge was used and the same problem occurred.No further information was provided.This report captures the event for two of two cartridges.

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

Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that 12 additional complaints were received.There is no indication of a product malfunction.This production order /batch ce08147 is part of an ongoing potential malfunction investigation #capa-009710.Conclusion: based on the investigation, no product deficiency was identified.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: 9809268
• MDR Text Key: 182698196
• Report Number: 2648035-2020-00226
• 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: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• 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
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: Z9002 IOL, SERIAL#: (B)(6); Z9002 IOL, SERIAL#: (B)(4)
• Patient Age: 88 YR