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

Model Number PSCST30

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

Implant and explant date: if implanted or explanted, give date: not applicable, as the cartridge is not an implantable device.An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) came out of the loader while inserting into the patient's left eye.The haptic and optic had touched the patient's eye.There was no medical intervention, surgical intervention, or patient injury.The patient is doing well.No additional information was provided to johnson & johnson surgical vision.

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

Additional information section d10: device available for evaluation? yes.Returned to manufacturer on: 1/17/20.Section h3: device returned to manufacturer ¿ yes.Device evaluation: lubricant material residues and loose particles can be observed on the lens surface.No damaged was observed on lens, it looks in good condition.Based in the information provided and the sample analysis the reported issue could not be verified.Product quality deficiency was not identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: in follow up mdr #1, the device evaluation for the lens (concomitant product) was inadvertently reported.Therefore, this follow up report #2 captures the product evaluation for the cartridge.The following sections have been updated accordingly: section d10: device available for evaluation? no section h3: device returned to manufacturer ¿ no section h6: method codes: 4114.Device evaluation: the device was not returned at 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 records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed three additional complaints for this production order number have been received.Batch ce04907 is part of the bracketing of capa-009710.There is a potential product malfunction being investigated 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.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: 9380121
• MDR Text Key: 169141176
• Report Number: 2648035-2019-01252
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)200522(10)CE04907
• 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,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2020
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CE04907
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/17/2020
• 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 LENS SN# (B)(6)
• Patient Age: 78 YR