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

Model Number 9081X

Device Problems Nonstandard Device (1420); Device Handling Problem (3265)

Patient Problems Inflammation (1932); Discomfort (2330)

Event Date 06/19/2021

Event Type  Injury  

Manufacturer Narrative

Patient age or date of birth, weight, and ethnicity: unknown/no information.Device information.The lot number provided for the tablets is 90361.However, the information for this number cannot be correlated to product information as would a valid tablet lot number.Therefore, the information provided reflects information for the provided kit lot number zj04628.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

Consumer reported that she experienced severe irritation in her right eye after wearing her contact lenses when she maintained them with consept 1-step solution.She visited an eye clinic and the physician informed her that the eye was "inflamed".The previous day she had put in her contact lenses again which she took care of with concept 1-step solution.However, her eye got irritated again.Her physician said that her solution might not be neutralizing.The following medication was prescribed ofloxacin 0.5% and fluorometholone 0.1%.Additionally, the customer did not shake-invert the container three times before wearing her contact lenses as required per the directions for use.The patient was still recovering at the time this event was reported.No further information was provided.

Manufacturer Narrative

Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: oct 30, 2021.Section h3: evaluated by manufacturer: yes.Lot number 90361 was subsequently correlated to the tablets through the investigation provided by the manufacturer.Expiration date: november 2022.Date of manufacture: december 2020.Device evaluation: a product quality deficiency could not be determined.The samples which were analyzed against the received nature of complaint complies as per specification.Results of retain sample and return samples found comparable no abnormality was observed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Complaint log of the past two years from the date of receipt of the complaint 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: CONCEPT 1-STEP
• Type of Device: TABLETS
• 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: 12208293
• MDR Text Key: 263210213
• Report Number: 2020664-2021-07066
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 14987617002814
• UDI-Public: (01)14987617002814(17)221130(10)ZJ04628
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: 9081X
• Device Catalogue Number: 94087JA
• Device Lot Number: ZJ04628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• 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: CONCEPT 1-STEP, LOT ZJ04628 SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Sex: Female