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

Model Number 1MTEC30

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: exact date unknown, not provided.Best estimate (b)(6) 2019.If implanted; if explanted; give date: n/a (not applicable).The cartridge is not an implantable device.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the doctor is seeing an increase in plaques coming from the cartridges at time of lens injection.Maybe 50% of recent cases.The doctor shared two (2) specific case images that occurred recently with a flake of material that goes in from the injector with the lens.It was also stated that the debris is easy to take out by irrigation and aspiration (ia).Follow-up noted that they have had this issue before (approx.2 years ago) and it went away from some time and manifested again around the beginning of summer, but no exact dates or other specific information provided.It was learned that all patients had no adverse events and one of the doctor¿s colleagues did leave it in the eye and the patient was fine.No other information was provided.2 mdr reports are required, one for each case reported.This mdr is to capture case#2.Another mdr is submitted to capture case #1.

Manufacturer Narrative

Device available for evaluation; returned to manufacturer on: 10/29/2019.Device evaluation: the sample was evaluated by a principal engineer and no damages or flaws were observed.The complaint reported was not verified and no product deficiency was identified.In addition, photos were provided and were reviewed.The photo shows as per customer information two cases with the flake (debris/particle) sitting on posterior aspect of the lens.However, the origin or the source of the material is unknown.Based on the sample evaluation that was returned, no damages were identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional investigations were received related to this production order.Conclusion: 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: 9188908
• MDR Text Key: 166321266
• Report Number: 2648035-2019-01095
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200626(10)CE06376
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE06376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• 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