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 10/03/2021

Event Type  Injury  

Manufacturer Narrative

Although supplier lot number 89979 was provided, expiration date: unknown, has not been provided by external manufacturer, and udi are unknown.Additional concomitant product contact lens, unknown model and type.Device manufacture date: unknown, has not been provided by external manufacturer.However, kit lot number information is as follows: kit lot# zj04287, catalog # 94017ja, udi #: (b)(4), expiration date 10/31/2022, manufacture date 11/18/2020.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Event Description

Consumer reported that he experienced severe irritation in his eyes when wearing his contact lenses which he maintained with consept 1-step.After an hour he visited an eye clinic.He was informed that his eye was scratched and was prescribed hyaluronic acid eye drops and levofloxacin ophthalmic solution.It was reported the product was properly used.At the time of this call his eyes had recovered.No further information was provided.

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.Per the completed investigation results the tablet manufacturing date is october 2020, and the expiration date is november 2022.The specific day(s) were not provided.Section d4: device expiration date: november 2022.Section h4: device manufacture date: october 2020.Device evaluation: the retain and return samples 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: 12756732
• MDR Text Key: 284965108
• Report Number: 2020664-2021-07673
• 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: 01/20/2022

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: 9081X
• Device Catalogue Number: 40840WW
• Device Lot Number: 89979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOLUTION LOT# ZJ04286
• Patient Outcome(s): Required Intervention
• Patient Sex: Male