MAUDE Adverse Event Report: PIRAMAL PHARMA LIMITED CONSEPT 1-STEP; ACCESSORIES, SOFT LENS PRODUCTS

Model Number 9081X

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

Patient Problems Purulent Discharge (1812); Inflammation (1932); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Age or date of birth, weight, and ethnicity: unknown/no information.Date of event: exact date unknown, not provided, best estimate is during 2021.Information for lot number: zj05113, expiration date: nov 30, 2022, and udi number: (b)(4) is for the kit lot number as the associated lot number specific to the tablets was not provided.Manufacture date: mar 28, 2021, is for the kit lot number as the associated lot number specific to the tablets was not provided.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

Event Description

Received report from a consumer who experienced severe irritation in both eyes.The severe irritation occurred four out of nine times when wearing her contact lenses.She cared for her contact lenses with concept 1-step solution.Consumer reassured us that she added the neutralizing tablet and the solution had turned pink.She shook the lens case many times, nevertheless she still experienced irritation four times.On one occasion she re-did the care of her contact lenses, but she still experienced irritation.Patient visited an eye clinic and steroids were prescribed; the name was not provided.After using the medication the irritation subsided.At the time of this report, she was experiencing mucus discharge.She refused to be contacted regarding the course of her symptoms.No further information was provided.This report is for the neutralizing tablets.A separate report is being submitted for the solution.

Manufacturer Narrative

Additional information: device evaluation: product testing could not be performed as the product was not returned for analysis.The related lot# for the tablets was not provided; therefore, retained sample could not be pulled for testing purposes.The reported event could not be verified.Complaint log of past two year from the date of receipt of the complaints has been reviewed and no justified complaint of similar nature was found.Manufacturing record review: a review of the records could not be performed as the product lot/serial number was not provided.Conclusion: based on the investigation, no product deficiency could be determined.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): PIRAMAL PHARMA LIMITED; plot 67-70, sector 11; pthampur; madhya pradesh, madhya pradesh 45477 5; IN 454775
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12595440
• MDR Text Key: 275460487
• Report Number: 2020664-2021-07375
• Device Sequence Number: 1
• Product Code: LPN
• UDI-Device Identifier: 14987617002012
• UDI-Public: (01)14987617002012(17)221130(10)ZJ05113
• 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

• Date FDA Received: 10/07/2021
• 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: 40505JA
• Device Lot Number: ZJ05113
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CONSEPT 1-STEP SOLUTION LOT ZJ05112; CONSEPT 1-STEP SOLUTION LOT ZJ05112
• Patient Outcome(s): Required Intervention
• Patient Sex: Female