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

Model Number 07167X

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

Patient Problems Irritation (1941); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event: exact date unknown, information not provided.Best estimate is two days prior to the event being reported to j&j.(b)(6) 2020.Lot#: unknown, information not provided.Expiration date: unknown, as the lot# was not provided.Unique identifier: unknown, as the lot# was not provided.Device manufactured date: unknown, as the lot# was not provided.Concomitant medical products: consept 1-step neutralizing tablet lot# 84066 or lot# 82358, exact lot# used with solution at the time of the event is unknown.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Consumer reported that after using concept 1-step product, her eyes were severely irritated when wearing her contact lenses.Consumer explained that when she added the neutralizing tablet to the solution, bubbles suddenly generated.One minute after adding the neutralizing tablet the solution would bubble and the tablet would completely dissolve.Whenever this occurred, she always tried again to ensure she is taking care of her lenses appropriately.Two days prior to this report the patient experienced irritation in her right eye even though she took the appropriate steps.Reportedly, her contacts were left in the solution about seven hours prior to use and that she did add the neutralizing tablet to the solution as the color turned pink when she checked.This occurred five times, and the same contact lens case has been used for more than six months.As of the time of reporting this event, the consumer could not wear contact lenses.She had sought medical attention and the ophthalmologist prescribed an ophthalmic solution.Through follow-up it was learned the consumer was prescribed hyaluronate na ophthalmic solution and levofloxacin ophthalmic solution.The consumer¿s condition has now resolved.No further information was provided.Two different lots-bottles of solution and two different lots of tablets were used.Therefore, four separate reports are being submitted for this event, one for each product.

Manufacturer Narrative

Corrected data: in the initial mdr section h6 patient code 2146 was provided, however the appropriate code for irritation is 1941.Therefore, the code is being updated in this supplemental filing.

• Brand Name: CONSEPT 1-STEP
• Type of Device: SOLUTIONS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10659871
• MDR Text Key: 211005434
• Report Number: 3004178847-2020-00023
• 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
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 07167X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/10/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention