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

Model Number 1MTEC30

Device Problems Difficult to Insert (1316); Premature Activation (1484)

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

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Lot: unknown, not provided.Expiration date: unknown, as lot number was not provided.Implant date: not applicable as this is not an implantable device.Explant date: not applicable as this is not an implantable device.Device manufacturing date: unknown, as the lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an iol, diopter and model unknown, loaded incorrectly, causing the backup lens to be used.This event was identified during the procedure.There was patient contact.Reportedly there were no complications or injuries and the patient has recovered.No further information was 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 (b)(4) and capa-010215.

Manufacturer Narrative

Corrected data: in follow-up report #2 the date 7/2/2020 was provided in section g4, however on august 25, 2020, it was clarified with the clinical research team that on july 2, 2020 the database is locked which means that no more data can be entered into the study.The data had to be analyzed and reviewed to correlate the device and patient information.This review was completed on july 7, 2020, therefore, the correct aware date for reporting purposes is july 7, 2020.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: follow-up information was received indicating the subject exited the study.The database was locked july 02 2020.Additional comments received state the intraocular lens (iol) was loaded incorrectly into the injector and could not be injected.No further information was provided.Corrected data: in the initial medwatch 2648035-2019-01308, section d11 reported the iol model zcb00 and serial# (b)(4).However, in section b5 stated that the iol diopter and model was unknown, this was an incorrect statement as the lens information was known and entered correctly in section d11.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Device evaluation: product testing on the cartridge could not be performed as the product was not returned.The reported complaint could not be verified.Manufacturing record review: a review of the records could not be performed as the product lot number was not provided.Conclusion: based on the investigation, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.

• 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: 9454902
• MDR Text Key: 179454715
• Report Number: 2648035-2019-01308
• 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,Followup,Followup
• Report Date: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2021
• 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 SERIAL# (B)(4)
• Patient Age: 66 YR