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 Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Date of event: unknown, information not provided.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, if explanted, give date: not applicable as this is not an implantable device.Device manufacture date: unknown as lot number was not provided.Device evaluation: sample is not available for investigation complaint could not be verified.Manufacturing records review: the manufacturing record evaluation could not be performed since the lot number is unknown.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 doctor had couple of 1mtec30 cartridges more over the past months which had white syrup substance infiltrate into the eye as the zcboo lens was being implanted.Luckily the doctor was able to aspirate the substance out of the eye.In all the cases zcb00 lens were used and healon duet was used as concomitant product.Reportedly the products were stored in the site at a temperature between 58-degree fahrenheit and 68 degree fahrenheit.Per customer the material looked fibrous and was coming out of leading edge and not the trailing edge.The exact quantity is unknown.This event will capture information for 1 cartridge.Another report is being submitted for other cartridge.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 nr-0148919 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: 8801203
• MDR Text Key: 151425043
• Report Number: 2648035-2019-00734
• 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
• Report Date: 01/01/2005,11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: UNKNOWN
• 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: ZCB00 LENS SN: UNKNOWN, HEALON DUET LOT# UNKNOWN; ZCB00 LENS SN: UNKNOWN, HEALON DUET LOT# UNKNOWN