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

Model Number 1MTEC30

Device Problem Contamination (1120)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

Expiration date: unknown, as the lot number was not provided.Lot number: unknown, information not provided.Udi number: a partial udi number is known, as the lot number was not provided.If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.Device manufacture date: unknown as lot number was not provided.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 9 of the 1mtec30 cartridges had what looked like a white syrup substance infiltrate into the eye as the zcb00 model lens was being implanted.There were 9 cartridges that were reported.Reportedly all 9 patients were not harmed but extensive time was taken to vacuum the substance out of the eye using irrigation and aspiration on the phaco machine.Patient was doing fine.This report is to capture third out of 9 cartridges.There are 8 other reports being submitted for this issue.No further information provided.

Manufacturer Narrative

Additional information was received and it was learnt that the date provided in initial report date received by manufacturer: 4/7/2019 was incorrect.The correct received date was 4/5/2019.Lot number: ce00879.Udi number: (b)(4).Expiration date: 1/24/2020.Device manufacture date: 1/24/2019.Device evaluation: the samples were received.Only a box with 26 unused cartridges was received.The sealed packages containing the cartridges were evaluated, no damages were observed.No particle or debris was observed on the cartridges.The reported cartridge with the substance was not received.Therefore, the product testing could not be performed, and the complaint issue reported could not be verified.Based on the product returned evaluation a product quality deficiency or product malfunction could not be determined.On june 11, 2019, special instructions were executed in order to evaluate the ten (10) of the twenty-six (26) cartridges from production order (b)(4) / batch ce00879 (model 1 mtec30) returned by the customer.The purpose of the special instructions was to perform the evaluation of the units by performing a visual inspection of each unit following the criteria of m1770, "procedure for inspection of cartridges coated with biocoat" and executing the lens delivery per the directions for use z311145, "dfu,1mtec30(mltlngl)anasco cartridge box¿.The execution of the special instructions was performed in the controlled iso 7 manufacturing area with the manufacturing engineer, manufacturing supervisor, and the manufacturing quality engineers present to observe each delivery performed by the trained operator per the special instructions.All ten (10) units passed the visual inspection and during the lens delivery there was no "white syrup substance" observed.Based on the results of these special instructions using the un-opened cartridges provided by the customer the condition of "white syrup substance" observed during lens delivery was not confirmed.The ten (10) units were not discarded and were returned to the complaint laboratory.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 and precautions along with warnings for the proper use and handling of the device.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision 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: 8583809
• MDR Text Key: 144265989
• Report Number: 2648035-2019-00541
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(10)UNKNOWN
• 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: 01/01/2005,11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE00879
• 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: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LENS MODEL ZCB00 SN# UNKNOWN