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 as the cartridge is not an implantable device.If explanted, give date: 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 a model z9002 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.No further information was provided.This report captures the event for one 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 (b)(4) and capa-010215.

Manufacturer Narrative

Corrected data: it was reported in medwatch 2648035-2020-00225,follow-up #1 that no similar complaints were received for this production order.However, additional complaints were received, therefore, the following information should have been included."a search of the production order revealed thirteen (13) additional investigations requests.There is no indication of a malfunction.The production order /batch ce08147 is part of an ongoing potential malfunction investigation #capa-009710." all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: section d10: device available for evaluation, yes.Section d10: returned to manufacturer on, 02/25/2020 section h3: device returned to manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The product returned was a plastic bag with a tray and a cartridge.Residues of viscoelastic were observed on the cartridge.The product was handled.No damage to the cartridge was observed.No lens was returned.Based on the visual evaluation of the returned unit it could not be determined that the cause of the issue reported is related to the manufacturing process since there are indications the unit was handled and prepared for lens insertion at the surgical stage.A product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no similar complaints were received for this production order.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: 9809269
• MDR Text Key: 182799397
• Report Number: 2648035-2020-00225
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530737
• UDI-Public: (01)05050474530737(17)241104
• 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,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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• 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