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

Model Number 1MTEC30

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device; therefore, not explanted.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the platinum cartridge 1mtec30, lot cd08721, appeared deformed during product handling and prior to insertion.No further information provided.

Manufacturer Narrative

Device evaluation: the product was not returned to the manufacturing site; therefore, the complaint issue reported was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Historical data analysis: a search of complaints revealed 3 other complaints have been received for this production order number.One investigate request is a duplicate which was inadvertently initiated.The other 2 investigations were completed and product deficiency was not confirmed.In addition, there is no increase in trending for the reported complaint type ¿tip deformed¿ for the 1mtec30 models.Conclusion: as a result of the investigation there is no indication of a quality product deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

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: 8485665
• MDR Text Key: 141015432
• Report Number: 2648035-2019-00426
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)190807(10)CD08721
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• 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
• Report Date: 01/01/2005,11/10/2020

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: 08/07/2019
• 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: 03/05/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 05/28/2019; 10/25/2020
• Supplement Dates FDA Received: 06/19/2019; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1