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

Model Number 09081X

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Irritation (1941)

Event Type  Injury  

Manufacturer Narrative

Age/date of birth: unknown, information not provided.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.Expiration date: unknown, information not available at this time.Unique identifier: udi# is unknown at this time.Concomitant products: consept 1-step solution lot# zh04523 or an unknown solution lot#, exact lot# used with tablet at the time of the event is unknown.Device manufactured date: unknown, information not available at this time.(b)(4).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

Device evaluation: the device was not received for evaluation, however retained product testing for physical appearance, neutralization and dissolution time and ph was conducted by the manufacturer.Results were within established acceptance criteria.Manufacturing record review: manufacturing and environmental monitoring records were reviewed and found to conform.No process and/or material changes were noted.No non-conforming materials were noted.Batch records were reviewed and found to be in order.Risk assessment is not affected.Conclusion: results obtained do not reveal any anomaly concerning the quality and efficacy of the product related to the customer''s complaint, no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.At the time of this report 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: 10659873
• MDR Text Key: 211007374
• Report Number: 2020664-2020-00050
• 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: 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 09081X
• Device Lot Number: 84066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention