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

Model Number PSCST30

Device Problems Device Damaged by Another Device (2915); Failure to Eject (4010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, not provided, but the best estimate date is during 2020.If implanted, give date: not applicable, cartridge is not an implantable device.  if explanted, give date: not applicable, cartridge is not an implantable device.  attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that lens ripped while inserting.Reportedly, half of the lens flew off the field and customer believes the reason for lens being ripped could have been due to the injector which has been replaced.The lens was partially inserted and removed during the same procedure.There was no patient injury, no incision enlargement, vitrectomy, or sutures required.The procedure was completed using another lens of the same model and diopter.Patient is doing fine.This report will capture the reported partial delivery related to the cartridge.A separate report will be submitted as part of voluntary malfunction summary report for the lens.No further information provided.

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 (b)(4).

Manufacturer Narrative

Additional information: additional information provided by the account indicated that the lens was stuck in the injector (cartridge).Device evaluation: no cartridge was returned.Only a tyvek lid with lot number identification was returned.Since cartridge was not returned, the product testing could not be performed.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records and related documents for the production order of the device were reviewed and no deviation or non-conformity was found during the mrr (manufacturing record review).The units were manufactured and released according to specifications.A search in the complaint system revealed only one additional complaint has been received for this production order number.No product deficiency was identified.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.

Manufacturer Narrative

Corrected data: in review, it was noted that the issue was actually ¿cartridge leading to lens damage¿; however, this was inadvertently not coded for in the initial or supplemental #1 and #2 mdr reports; therefore, it is captured and coded for in this supplemental mdr report #3.The following fields were updated accordingly: section h6: device code: 2915- damaged by another device.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: 10371195
• MDR Text Key: 201832415
• Report Number: 2648035-2020-00585
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474530034
• UDI-Public: (01)05050474530034(17)201016(10)CE09371
• 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: 01/01/2005,11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Model Number: PSCST30
• Device Catalogue Number: PSCST30
• Device Lot Number: CE09371
• 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: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LENS MODEL Z9002 SN: (B)(4).