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

Model Number 9081X

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

Patient Problems Corneal Abrasion (1789); Discomfort (2330)

Event Date 01/02/2022

Event Type  Injury  

Event Description

Consumer reported that she experienced irritation in her right eye when wearing her contact lenses after taking care of them with consept 1-step solution.Reportedly, the product was used properly.The contacts lenses used were acuvue oasys (bi-weekly).The bottle was newly opened and so were the contacts, opened (b)(6) 2022, and used.The next morning (b)(6) the consumer again experienced irritation when wearing the contact lens.Consumer sought medical attention at an eye clinic.The doctor said her cornea had small scratches, but the cause was unknown.She was prescribed tearbalance ophthalmic solution 0.1%, and gatiflo ophthalmic solution 0.3%, and wore eyeglasses.The symptoms subsided.No further information was provided.This report is for the neutralizing tablets.A separate report is being submitted for the disinfecting solution.

Manufacturer Narrative

Expiration date: the expiration date is december 2022.Unique identifier (udi) number: udi has not been supplied by the external manufacturer.Device manufacture date: the manufacture date is january 2021.Device has not returned for evaluation.Therefore, a visual analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Manufacturer Narrative

Additional information section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: apr 9, 2022.Section h3: evaluated by manufacturer: yes.Device evaluation: the retain and return sample were analyzed.The samples comply to specifications.Results of retain sample and return sample found comparable, no abnormality observed.A product quality deficiency could not be determined.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: CONSEPT 1-STEP
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 13464074
• MDR Text Key: 285250797
• Report Number: 3012236936-2022-00204
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P850088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• 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: 40840WW
• Device Lot Number: 90996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SOLUTION LOT # ZJ05556, ACUVUE OASYS CONTACT LENS
• Patient Outcome(s): Required Intervention
• Patient Sex: Female