MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problem Contamination (1120)

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

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

If implanted, give date: not applicable, cartridge is not an implantable device.If explanted, give date: not applicable, cartridge is not an implantable device.Initial reporter first and last name: unknown/not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the customer lost confidence in the lot for the suspect 1mtec30 cartridge, due to incident where white substance came out of the 1mtec cartridge during surgery and deposited into the eye of the patient.The white substance was present at one day post-op.The patient was not harmed and there was no inflammation at the one day post-op.The customer is returning the entire case of cartridge.It was learnt that the customer doesn¿t want to be contacted for any additional information that we may need.No other information was provided.

Manufacturer Narrative

Additional information: device evaluation: the device visual investigation was not completed as suspect product was not received.The reported debris from cartridge was not verified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search of complaints related to the production order (po) number performed.The search revealed two (2) additional investigations related to this po.One file has been closed, with no product deficiency identified, and the other is pending completion.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.

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.

• Brand Name: PLATINUM 1 SERIES
• 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: 9115178
• MDR Text Key: 159937168
• Report Number: 2648035-2019-01042
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200429(10)CE03960
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• 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
• Initial Date Manufacturer Received: 08/29/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 01/02/2020; 10/25/2020
• Supplement Dates FDA Received: 01/24/2020; 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1