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.Implant date, explant date: not applicable as this is not an implantable device.(b)(6).All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that something like lint or debris of a 1mtec30 cartridge was attached to the top of the intraocular lens (iol) when the lens was being implanted.It was indicated that the foreign matter was removed with forceps and there was no patient injury reported.No additional information was provided.

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on: 07/02/2019.Device returned to manufacturer: yes.Device evaluation: the debris along with the product (cartridge) were received on 07/02/2019.The debris was received in the tray and was sent to an outside lab for analysis.Visual inspection using microscope magnification was performed on the cartridge.No physical damage was observed on the cartridge.The reported issue was verified; but, based on the product return evaluation, a product quality deficiency nor a product malfunction could be determined.The foreign material was analyzed by fourier transform infrared (ftir) spectroscopy with a perkinelmer spectrum 200 ftir spectrometer using horizontal attenuated total reflectance (hatr) sampling mode.Ftir analysis indicates the foreign material is consistent with a polypropylene material.Polypropylene can be any type of plastic material.Visual inspection of the returned cartridge showed no damage observed; therefore, it cannot be confirmed if the lint/debris reported came from the cartridge.Based on the results of the investigation, it cannot be confirmed that the foreign matter/material originated as part of the cartridge manufacturing process.The customer's reported complaint was not verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no other complaints were received for this production order number.As a result of the investigation there is no indication of a product quality 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 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: 8792011
• MDR Text Key: 151129707
• Report Number: 2648035-2019-00726
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200124(10)CE00878
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/12/2020

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: 01/24/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE00878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• 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: 06/18/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 07/30/2019; 10/25/2020
• Supplement Dates FDA Received: 08/19/2019; 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZCB00 INTRAOCULAR LENS, SERIAL #(B)(4); ZCB00 INTRAOCULAR LENS, SERIAL #(B)(4)