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

Model Number 1MTEC30

Device Problems Crack (1135); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2018

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 1mtec30 cartridge tip was observed stressed and split during lens insertion.Reportedly, there was a patient contact as the cracked lens passed through the distal end of the device.However, there was no patient injury reported and no surgical intervention was required.No additional information provided.

Manufacturer Narrative

Device available for evaluation: yes.Returned to manufacturer on: 09/12/2018.Device returned to manufacturer: yes.Device evaluation: the product associated to the complaint was received on 09/12/2018.The cartridge was received in the original tray with the original tyvek lid.Traces of viscoelastic were observed in the cartridge tube.The cartridge is cracked and deformed at the tip with a dent or smash condition.The reported issue was verified.A product quality deficiency could not be determined based on the observations of the returned cartridge.Manufacturing records review: the manufacturing process record (po) was evaluated and the devices were manufactured within specifications.The units were released according to specification.A search revealed no additional investigation request for this process record.Labeling review: the directions for use (dfu) was reviewed.The directions for use instructions provide the customer with information on properly handling the product.As a result of the investigation, no product deficiency was identified.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 nr-(b)(4) and capa-(b)(4).

• Brand Name: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7828663
• MDR Text Key: 118749588
• Report Number: 2648035-2018-01173
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)190112(10)CD00392
• Combination Product (y/n): Y
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/03/2020

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: 01/12/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CD00392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• 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: 08/02/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 10/04/2018; 10/25/2020
• Supplement Dates FDA Received: 10/28/2018; 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1