MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. CONSEPT 1-STEP; ACCESSORIES

Model Number OXYTC

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information: age/date of birth: unknown, information not provided.Date of event: unknown, information not provided.Lot#: unknown, information not provided.Unique identifier: udi# is unknown as lot number was not provided.Expiration date: unknown, as lot number was not provided.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/serial number was not provided.Conclusion: based on the investigation, no product deficiency could be determined.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Received report from consumer regarding the lens case for the consept 1-step product.Consumer stated that the white filter of the lens case lid got mold.This is not the first time the consumer has used the product.Reportedly, the consumer made a bulk purchase for a one year''s supply and has used some bottles.Consumer mentioned that it's possible she did not allow the lens case to dry completely after using it, and did not know when to change the lens case because she has so many in stock.There was no impact to the user.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: CONSEPT 1-STEP
• Type of Device: ACCESSORIES
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10353957
• MDR Text Key: 203653759
• Report Number: 3004178847-2020-00016
• 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
• 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: 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
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 10/25/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOLUTION & TABLETS LOT#''S UNKNOWN/NOT PROVIDED