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

Model Number 1MTEC30

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

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 concomitant medical products: (b)(4) viscoelastic, lot 027038; phaco tip (b)(4), lot f92186.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that two foreign filaments were found in the anterior chamber of the patient's eye right after the intraocular lens (iol) implantation and the irrigation/aspiration (i/a) procedure.There was a delay of 10 minutes in the procedure but no secondary surgical or medical intervention was required.The account believes that the filaments are coming from either the cartridge, the viscoelastic or the phaco tip; therefore 2 mdrs will be filed.This is to record the cartridge.A separate report will be submitted for the viscoelastic endocoat.

Manufacturer Narrative

Device available for evaluation: yes, returned to manufacturer on 3/27/2019.Device returned to manufacturer: yes.Device evaluation: the 1mtec30 cartridge was received on 03/27/2019 and examined under magnification.A fiber/filament like particle was detected and sent as received to our third-party laboratory for identification.Fourier transform infrared (ftir) analysis indicates that the foreign filaments are consistent with a cellulosic material (e.G.Cotton, rayon, lint).The manufacturing process of 1mtec30 unfolder platinum 1 series have a potential exposure to this type of material due to handling and/or use.The process batch data was reviewed and no indications of deviations were found.The cartridge was found complete and there is no missing portion of the cartridge that could be associated to the description of the customer of a foreign filament.Furthermore, the 100% microscope inspection data was also reviewed and no process control deviations had been observed and no other debris deposition event had been reported during the process completion.The reported foreign material was verified.However, based on the analysis of the returned product and identified particle; a product quality deficiency nor a product malfunction could not be determined.Based on the manufacturing record review, analysis of the returned product, historical complaint review and non-conformance/capa review there is no indication of a product malfunction.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.No non-conformance reports (nc's) and no exemption report (er's) were found associated to this production order.A search revealed that no additional investigation request for this lot number has been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: based on the manufacturing records review, analysis of the returned product and non- conformance/capa review, there is no indication of a product malfunction.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA
• MDR Report Key: 7546803
• MDR Text Key: 109361241
• Report Number: 2648035-2018-00783
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)190125(10)CD01199
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/26/2019

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: Physician
• Device Expiration Date: 01/25/2019
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CD01199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 04/08/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1