MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. LIPIFLOW ACTIVATOR II

Lot Number 1804306

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

Customer reported that upon removing product from the box the inner pouch package was already opened.There was no patient involvement.

Manufacturer Narrative

Device available for evaluation? yes.Returned to manufacturer on: 10/10/2019.Device returned to manufacturer? yes.Device evaluation: device history record showed no related non-conformity or deviations issued during manufacturing the activator lot# 1804306.All devices met material, assembly and performance specifications at the time of product released.An evaluation of the returned device was conducted.Device was returned outside of its original packaging.The primary packaging was received opened, but seal markings were visible on the tyvek pouch.No debris/fibers or any damage observed on the returned product.How and when the reported event occurred is unable to be determined.Reported issue was confirmed.Manufacturing record review: per manufacturing records review report, no related non-conformity or deviations were issued during manufacturing the activator lot# lot# 1804306.All devices met material, assembly and performance specifications at the time of product released.Based on the information results, there is no indication of a product quality deficiency.Johnson & johnson will continue to monitor these types of complaint types.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: LIPIFLOW ACTIVATOR II
• Type of Device: LIPIFLOW ACTIVATOR
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9183159
• MDR Text Key: 194473633
• Report Number: 3008169506-2019-00008
• Device Sequence Number: 1
• Product Code: ORZ
• UDI-Device Identifier: 20859623006333
• UDI-Public: (01)20859623006333(17)220212(10)1804306
• Combination Product (y/n): Y
• PMA/PMN Number: K161357
• 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: 01/01/2005,11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2022
• Device Lot Number: 1804306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• 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