MAUDE Adverse Event Report: JOHNSON AND JOHNSON SURGICAL VISION, INC. OXYSEPT1; SOLUTIONS

Model Number 7167X

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation: the complaint device was not returned; therefore, an investigation could not be performed.The consumer's reported complaint could not be confirmed.Manufacturing records review: a record review could not be performed as the lot number of the complaint device was not provided.Labeling review: the directions for use (dfu) provides instructions, precautions, and warning for the proper use and handling of the product.The dfu instructs the consumer to invert the lens cup three times after placing the lenses in the solution.Therefore the solution can reach the top of the lens case.Based on the historical complaint review and non-conformance/capa review, there was no indication of a malfunction or product quality deficiency.Attempts have been made to obtain missing information; however, to date no response was received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

A consumer reported placing their lenses in the oxysept solution and after decontamination, the case was moldy on the top.No further information was provided.

Manufacturer Narrative

Corrected data: in review of the complaint; it was noted that method code 3331 was inadvertently populated within the initial report.The reference to a manufacturing record review was correctly stated in the mfr narrative.Alternative report identification number: (b)(4).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: OXYSEPT1
• Type of Device: SOLUTIONS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; 1700 east st. andrew place; santa ana CA 92705
• MDR Report Key: 7733624
• MDR Text Key: 115525269
• Report Number: 3004178847-2018-00008
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: P850088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/29/2020

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: Lay User/Patient
• Device Model Number: 7167X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• 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: 07/30/2018
• Supplement Dates Manufacturer Received: 07/31/2018; 10/25/2020
• Supplement Dates FDA Received: 10/28/2018; 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXYSEPT LENS CASE & NEUTRALIZING TABLETS, LOTS UNK.; OXYSEPT SOLUTION & TABLETS UNKNOWN LOT NUMBERS.