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

Model Number 1MTEC30

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Expiration date: unknown, as the lot number was not provided.Lot number: unknown, information not provided.Udi number: unknown, as the lot number was not provided.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).Device manufacture date: unknown, as the lot number was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Our johnson and johnson staff went to the site to personally witness the events.They reported that there appears to be material transferred onto the intraocular lens (iols) from the cartridges.All of the cartridges used and sent back are 1met30 cartridges.The lens remains in the patients' eye.This file is created to capture reports from our staff who returned a number of lenses where the issue of lenses being observed with viscous material coming from the 1mtec cartridges (with varying levels of visibility ¿ some very mild and others slightly more visible).No other 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

Section d10: device available for evaluation?: yes.Returned to manufacturer on: 3/17/2020.Section h3: device returned to manufacturer?: yes.Device evaluation: the complaint units were visually inspected in the customer complaint laboratory in santa ana, ca.The analysis revealed that no physical damage or significant visual flaws were observed.Based on the inspection performed, the complaint issue was not verified.However, the parts will be used for the continued investigation under a capa-009718.Manufacturing record review: the manufacturing process record could not be performed since the lot number of the complaint product is unknown.A complaint search also could not be performed since the lot number of the complaint product is unknown.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.

• 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: 9386111
• MDR Text Key: 168300876
• Report Number: 2648035-2019-01266
• 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
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• 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