MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. OXYSEPT; ACCESSORIES

Model Number OXYTC

Device Problems Contamination (1120); Component Missing (2306)

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

Event Date 06/18/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information: age/date of birth: unknown, information not provided.Gender/sex: unknown, information not provided.Exact date not provided, best estimate (b)(6) 2020.Lot#: unknown, information not provided.Unique identifier: udi# is unknown as the lot# was not provided.Expiration date: unknown, as lot number was not provided.(b)(6).Device manufactured date: unknown, as lot number was not provided.Device evaluation: product testing could not be performed as the product was not returned.The reported event could not be verified.Manufacturing record review: a review of the records could not be performed as the product lot number was not provided.Conclusion: based on the investigation, no product deficiency could be determined.It is unknown if the product was used per the directions for use.Attempt(s) have been made to obtain missing information; however, to date, no response has been received.All.

Event Description

Optician reported that one of her patients complained that her triple pack of oxysept only contained one lens case when they used to have three.After two months of using the lens case, mold started to appear on it.The triple pack was purchased in (b)(6) 2020.No further 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 nr-0148919 and capa-010215.

• Brand Name: OXYSEPT
• Type of Device: ACCESSORIES
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10281206
• MDR Text Key: 206864183
• Report Number: 3004178847-2020-00014
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: OXYTC
• Device Lot Number: UNKNOWN
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXYSEPT SOLUTION AND TABLETS LOT#S UNKNOWN