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 Eye Injury (1845); Hyperemia (1904); Discomfort (2330); Ptosis (2620)

Event Date 10/09/2021

Event Type  Injury  

Manufacturer Narrative

Device expiration date: only provided as november 2022.Udi number for tablets is unknown, however kit lot # udi is (b)(4).Device manufacture date: only provided as november 2020.Product information: kit lot # zj04628, disinfectant solution lot # zj04627, neutralizing tablet lot # 90361.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Event Description

A report was received from a consumer's wife that the consumer experienced severe irritation in his eyes when wearing his contact lenses which were taken care of cy using consept 1-step.The consumer initially experienced irritation on (b)(6) 2021.He wore his contacts the following day and experienced irritation to the extent he could not open his eyes, and the eye lids dropped.The consumer called an ambulance and went to the hospital.The attending physician instructed him not to wear contact lenses for a while because the center of his eyes became gelatinous.The consumer also suffered from fever that prevented him from going to the office for several days.One week later, the physician allowed him to wear contacts.On (b)(6) 2021, he wore his contact lenses which he took care of by using a new bottle of consept 1-step without any problems.However, when the consumer used the remaining solution of the previous bottle of consept 1-step, he experienced severe irritation again.In summary, symptoms reported were irritation, red eyes, eye lids dropped, and the center of his eyes became gelatinous.At the time of this report, consumer was recovering.No details of the prescribed drug, a diagnosis, or further information was provided.This report captures the event for the neutralizing tablets.A separate report is being submitted for the disinfecting solution.

Manufacturer Narrative

Additional information section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: dec 29, 2021.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.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.The complaint log for the past two years from the date of receipt of the complaints has been reviewed and no justified complaint of similar nature was found.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.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12888699
• MDR Text Key: 282051189
• Report Number: 2020664-2021-08093
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• 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: 40840WW
• Device Lot Number: 90361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISINFECTING SOLUTION LOT # ZJ04627
• Patient Outcome(s): Required Intervention
• Patient Sex: Male