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

Model Number 9081X

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperemia (1904); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Additional information: age, weight and ethnicity: unknown/no information.Date of event: unknown/no information, best estimate is during (b)(6) 2021.Expiration date: not available as the lot # was not provided.Unique identifier (udi) number: udi was provided since the lot number is unknown.Device manufacture date: not available as the lot # was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

Consumer reported that her eyes turned red and irritated after wearing her contact lenses which she maintained with the concept 1-step solution.This was the consumers first time using this solution.Her eyes were red everyday after using the solution.She visited an eye clinic and eye drops were prescribed however she did not recover.She visited another eye clinic and was informed to use epika, a product she previously used.After using epika her red eyes subsided and fully recovered.Consumer was using concept 1-step to remove stains from her contact lenses.She figured this was wrong because the stains were not removed.Consequently, she used concept rinsing solution but her red eyes persisted.Consumer did not provide any more information.This report is being submitted for the neutralizing tablets.A separate report is being submitted for the solution.

Manufacturer Narrative

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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: CONSEPT 1 STEP
• Type of Device: TABLETS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 12251080
• MDR Text Key: 264271146
• Report Number: 2020664-2021-07074
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9081X
• Device Catalogue Number: 40505JA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONCEPT STEP-1 SOLUTION LOT# UNK; CONCEPT STEP-1 SOLUTION LOT# UNK
• Patient Outcome(s): Required Intervention