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 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Implant date: not applicable as this is not an implantable device.Explant date: not applicable as this is not an implantable device.It was indicated that the device is not returning for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision has been submitted.

Event Description

It was reported that when inserting the intraocular lens (iol) into the eye, the surgeon noticed a foreign body was released into the eye along with the lens.The materiel was described as looking like ''a piece of the cartridge'' however the cartridge was intact.Additional information revealed there was no patient injury and the patient was doing fine post-operatively.No additional information was provided.

Manufacturer Narrative

Device evaluation: eleven sealed and unused cartridges were returned in their original packages to the manufacturing site.No damage and/or defects were observed on these units.The returned particle was sent for outside analysis where ftir (fourier transform infrared spectroscopy) analysis indicated that the foreign material is consistent with a mixture of polypropylene and inorganic salts (possibly a salt solution).Manufacturing process assessment: investigation request was evaluated with sme (subject matter expert) to address the complaint issue reported.A mixture of polypropylene can be any type of plastic material and the inorganic salts can be a salt solution used during surgery.Based on the information provided by the customer in the complaint record, the cartridge used for the surgery was intact.The unit used during the surgery was discarded and was not returned for evaluation.Without the used unit it cannot be confirmed if the foreign matter/material originated from the unit (cartridge).Product deficiency could not be determined.Manufacturing records review: the manufacturing records for the product was reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints have been 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 (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: 8745613
• MDR Text Key: 149553256
• Report Number: 2648035-2019-00670
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200124(10)CE00876
• 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: 01/01/2005,11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• 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: CE00876
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZXR00 INTRAOCULAR LENS SERIAL #: UNKNOWN; ZXR00 INTRAOCULAR LENS SERIAL #: UNKNOWN